The Analgesic Efficacy of Erector Spinae Plane Blocks in Patients Undergoing Posterior Lumbar Spinal Surgery for Lumbar Fracture.

OBJECTIVE: To investigate the postoperative analgesic efficacy of ultrasound-guided lumbar erector spinae plane (ESP) blocks in patients undergoing posterior lumbar spinal surgery for lumbar spinal fractures. METHODS: A total of 80 patients who were scheduled for posterior internal fixation for lumbar spinal fractures were divided into a patient-controlled analgesia (PCA) group or a combined ESP-PCA group. Numeric rating scale at rest and during movement, postoperative sufentanil consumption, and accumulative and effective bolus presses of PCA were recorded at 6, 12, 24, and 48 hours postoperatively. Numeric rating scale at rest and during movement was the primary outcome. Incidence of postoperative nausea and vomiting during the first 24-48 hours, pruritus and chronic postoperative pain, and dose of pethidine for rescue analgesia were also recorded. RESULTS: Numeric rating scale at rest and during movement at 6, 12, and 24 hours was lower in the ESP-PCA group (P < 0.001, P < 0.001, P = 0.0016 at rest; all P < 0.001 during movement). Lumbar ESP blocks diminished accumulative bolus presses and effective bolus presses of PCA at 6, 12, 24, and 48 hours postoperatively. Besides, patients in the ESP-PCA group had fewer demands for sufentanil and pethidine. The incidence of postoperative nausea and vomiting in the ESP-PCA group was lower than that in PCA group. CONCLUSIONS: PCA combined with lumbar ESP blocks provided superior postoperative analgesia for patients with lumbar spinal fractures treated with posterior internal fixation. Lumbar ESP blocks decreased postoperative opioid consumption and incidence of postoperative nausea and vomiting, thereby enhancing postoperative recovery.

Sedation with fentanyl and midazolam without oropharyngeal anesthesia compared with sedation with pethidine and midazolam with oropharyngeal anesthesia in ultrathin bronchoscopy for peripheral lung lesions.

BACKGROUND: In advanced lung cancer, precision medicine requires repeated biopsies via bronchoscopy at therapy change. Since bronchoscopies are often stressful for patients, sedation using both fentanyl and midazolam is recommended in Europe and America. In Japan, bronchoscopies are generally orally performed under midazolam and oropharyngeal anesthesia. Nasal intubation creates a physiological route to the trachea, causing less irritation to the pharynx than intubation via the oral cavity; however, the necessity of oropharyngeal anesthesia remains unclear. We aimed to compare the safety, patient discomfort, and diagnostic rates for oropharyngeal anesthesia and sedation with pethidine and midazolam (Group A) and sedation with midazolam and fentanyl without oropharyngeal anesthesia (Group B) for ultrathin bronchoscopy of peripheral pulmonary lesions (PPLs) via nasal intubation. METHODS: We retrospectively reviewed 74 consecutive potential lung cancer patients who underwent ultrathin bronchoscopies at the Hakodate Goryoukaku Hospital between July 2019 and June 2020. We reviewed the following: diagnostic rates; cumulative doses of lidocaine, midazolam, and fentanyl; hemodynamic changes; procedural complications in both groups. Pharyngeal anesthesia in group A was administered by spraying 2% (w/v) lidocaine into the pharynx. The chi-squared test was used for statistical analyses. RESULTS: There were no significant changes in hemodynamic parameters and complications. The mean level of discomfort for bronchoscopic examinations was significantly lower in Group B (2.39 vs. 1.64; P = 0.014), with no significant inter-group difference in the diagnostic yields for PPLs (63.0% vs. 71.4%; P = 0.46). CONCLUSIONS: Our findings indicate the advantages of sedation with fentanyl and midazolam without oropharyngeal anesthesia for ultrathin bronchoscopy through nasal intubation.

Meperidine pharmacokinetics and effects on physiologic parameters and thermal threshold following intravenous administration of three doses to horses.

BACKGROUND: Meperidine is a synthetic opioid that belongs to the phenylpiperidine class and is a weak mu receptor agonist. In horses there are a limited number of published studies describing the analgesic effects of systemically administered meperidine in horses. The objective of this study was to describe the pharmacokinetics, behavioral and physiologic effects and effect on thermal threshold of three doses of intravenously administered meperidine to horses. Eight University owned horses (four mares and four geldings, aged 3-8 years were studied using a randomized balanced 4-way cross-over design. Horses received a single intravenous dose of saline, 0.25, 0.5 and 1.0 mg/kg meperidine. Blood was collected before administration and at various time points until 96 hours post administration. Plasma and urine samples were analyzed for meperidine and normeperidine by liquid chromatography-mass spectrometry and plasma pharmacokinetics determined. Behavioral and physiologic data (continuous heart rate, step counts, packed cell volume, total plasma protein and gastrointestinal sounds) were collected at baseline through 6 hours post administration. The effect of meperidine administration on thermal nociception was determined and thermal excursion calculated. RESULTS: Meperidine was rapidly converted to the metabolite normeperidine. The volume of distribution at steady state and systemic clearance (mean ± SD) ranged from 0.829 ± 0.138-1.58 ± 0.280 L/kg and 18.0 ± 1.4-22.8 ± 3.60 mL/min/kg, respectively for 0.5-1.0 mg/kg doses. Adverse effects included increased dose-dependent central nervous excitation, heart rate and cutaneous reactions. Significant effects on thermal nociception were short lived (up to 45 minutes at 0.5 mg/kg and 15 minutes at 1.0 mg/kg). CONCLUSIONS: Results of the current study do not support routine clinical use of IV meperidine at a dose of 1 mg/kg to horses. Administration of 0.5 mg/kg may provide short-term analgesia, however, the associated inconsistent and/or short-term adverse effects suggest that its use as a sole agent at this dose, at best, must be cautiously considered.

Effects of oral premedication with tramadol, pregabalin or clonidine on shivering after spinal anaesthesia in patients undergoing hysteroscopic procedures.

BACKGROUND: Shivering is a common complication of neuraxial anaesthesia. We compared the efficacy of tramadol, clonidine and pregabalin in preventing post-spinal anaes-thesia shivering in hysteroscopic procedures. METHODS: A prospective, randomized, triple-blind, controlled clinical trial involving 120 ASA I-II women, aged 18-60 years. The patients were randomly allocated to receive either oral clonidine 0.2 mg (group C), tramadol 100 mg (group T), pregabalin 150 mg (group P) or placebo (group O) 90 minutes before spinal anaesthesia. The body tempe-rature was monitored at the forehead and tympanic membrane. The primary outcome was the occurrence of perioperative shivering. The secondary outcomes were the side effects and meperidine requirements to treat shivering. RESULTS: All groups had comparable demographic data. Group C showed the lowest incidence, severity and number of intraoperative and postoperative shivering attacks. The time to the first shivering attack was significantly longer in group C than the other groups and in group T than groups P and O. The severity of shivering attacks was comparable among groups C, T and P while being significantly lower than group O. Meperidine requirements were significantly lower in group C. Groups C, T and P had a significantly higher sedation score than group O. The incidences of dizziness, nausea and vomiting were highest in group T. CONCLUSIONS: Tramadol, pregabalin and clonidine seem to be effective oral premedications to reduce the incidence, frequency and severity of post-spinal shivering but clonidine proved to be more effective and tolerable.

Analgesic Efficacy and Adverse Effects of Meperidine in Managing Postoperative or Labor Pain: A Narrative Review of Randomized Controlled Trials.

BACKGROUND: Meperidine, a synthetic opioid, has a rapid onset and short duration of action. Mounting evidence has challenged meperidine's analgesic benefits, and concerns have been raised about its safety profile. Despite recommendations to restrict the prescription of meperidine, the drug remains frequently used. OBJECTIVES: The aim of this study was to evaluate the evidence regarding the efficacy and safety of meperidine for acute postoperative and labor pain. STUDY DESIGN: This was a narrative review of the analgesic efficacy and side effects of meperidine compared to other analgesic drugs for acute postoperative and labor pain in adults. SETTING: Randomized controlled trials that compared the analgesic efficacy and side effect profile of meperidine versus another analgesic drug in adult patients were evaluated. METHODS: A systemized search of randomized controlled trials studying meperidine for acute postoperative or labor pain in the adult patient population from PubMed, Medline, and EMBASE was performed. Included studies reported on different routes of meperidine administration including intramuscular, intravenous, and patient-controlled analgesia in various surgical procedures such as abdominal surgery, Cesarean section, gynecological surgery, orthopedic surgery, cardiothoracic surgery, as well as for labor analgesia. Meperidine's analgesic efficacy and safety profile were compared to other opioids (morphine, tramadol, fentanyl, buprenorphine, nalbuphine, and pentazocine), nonsteroidal anti-inflammatory drugs (ketorolac, diclofenac, and indomethacin), dipyrone, ketamine, and bupivacaine. RESULTS: A total of 62 randomized controlled trials published between 1972 and 2018 were reviewed. Meperidine had a similar or inferior analgesic efficacy compared to other analgesics for acute postoperative or labor pain. Meperidine was associated with more sedation and respiratory depression. LIMITATIONS: The sample sizes of many clinical studies were small, and therefore probably insufficiently powered to detect differences in uncommon side effects, such as central nervous system toxicity. In addition, some of the included clinical studies were old. CONCLUSION: Considering the availability of other effective analgesics with potentially fewer side effects, the use of meperidine for acute postoperative or labor pain should not be recommended. KEY WORDS: Acute postoperative pain, adverse effects, labor analgesia, meperidine, pethidine.

Effects of preoperative anxiety on postcesarean delivery pain and analgesic consumption: general versus spinal anesthesia.

Objective: The aim of this study was to determine the effects of preoperative anxiety on the postoperative pain and analgesic consumption in patients undergoing cesarean deliveries (CDs).Materials and methods: This observational cohort study included 160 women, with ages ranging from 18 to 40 years old and a 37-week minimum gestation, received general (Group 1, n = 80) or spinal (Group 2, n = 80) anesthesia during an elective CD. The State Anxiety Inventory (SAI), Trait Anxiety Inventory (TAI), and Somatosensory Amplification Scale (SSAS) were used to measure the prenatal anxiety. The postoperative pain intensity was evaluated using the Visual Analogue Scale (VAS), and the pain and analgesic requirements were recorded at the 1st, 6th, 12th, 18th, and 24th postoperative hours.Results: No statistically significant differences were found between the groups in the demographics, clinical characteristics, or laboratory parameters. In addition, there were no differences with regard to the mean SAI, TAI, and SSAS scores and the diclofenac and pethidine consumptions (p > .05). The 1st hour [4.15 ± 1.84 versus 3.28 ± 2.41, odds ratio (OR) = 0.832, 95% confidence interval (CI) = 0.725-0.956, p = .009], 6th hour (3.85 ± 2.02 versus 3.13 ± 1.51, OR = 0.793, 95% CI = 0.668-0.942, p = .008), and 12th hour (3.64 ± 2.11 versus 2.94 ± 2.03, OR = 0.851, 95% CI = 0.737-0.983, p = .028) VAS scores were lower in Group 2 than in Group 1. No correlations were noted between the SAI, TAI, and SSAS scores and the VAS.Conclusions: While the patients with preoperative SAI scores >45 and who underwent cesarean deliveries (CDs) with general anesthesia had higher pain intensity scores in the first 12 hours than those underwent CDs with the spinal anesthesia, no difference was observed between the groups in terms of the postoperative analgesic requirements. Evaluating the patient's anxiety state and psychiatric evaluation may be useful for decreasing the postoperative pain intensity. Further studies are needed to corroborate our findings.

Creation of a score to predict risk of high conscious sedation requirements in patients undergoing endoscopy.

BACKGROUND AND AIMS: The administration of intravenous conscious sedation to patients undergoing GI endoscopy carries a risk of cardiopulmonary adverse events. Our study aim was to create a score that stratifies the risk of occurrence of either high-dose conscious sedation requirements or a failed procedure. METHODS: Patients receiving endoscopy via endoscopist-directed conscious sedation were included. The primary outcome was occurrence of sedation failure, which was defined as one of the following: (1) high-dose sedation, (2) the need for benzodiazepine/narcotic reversal agents, (3) nurse-documented poor patient tolerance to the procedure, or (4) aborted procedure. High-dose sedation was defined as >10 mg of midazolam and/or >200 µg of fentanyl or the meperidine equivalent. Patients with sedation failure (n = 488) were matched to controls (n = 976) without a sedation failure by endoscopist and endoscopy date. RESULTS: Significant associations with sedation failure were identified for age, sex, nonclonazepam benzodiazepine use, opioid use, and procedure type (EGD, colonoscopy, or both). Based on these 5 variables, we created the high conscious sedation requirements (HCSR) score, which predicted the risk of sedation failure with an area under the curve of 0.70. Compared with the patients with a risk score of 0, risk of a sedation failure was highest for patients with a score ≥3.5 (odds ratio, 17.31; P = 2 × 10-14). Estimated area under the curve of the HCSR score was 0.68 (95% confidence interval, 0.63-0.72) in a validation series of 250 cases and 250 controls. CONCLUSIONS: The HCSR risk score, based on 5 key patient and procedure characteristics, can function as a useful tool for physicians when discussing sedation options with patients before endoscopy.

Extrapolation of Drug Clearance in Children ≤ 2 Years of Age from Empirical Models Using Data from Children (> 2 Years) and Adults.

BACKGROUND: The application of modeling and simulation approaches in clinical pharmacology studies has gained momentum over the last 20 years. OBJECTIVES: The objective of this study was to develop six empirical models from clearance data obtained from children aged > 2 years and adults to evaluate the suitability of the models to predict drug clearance in children aged ≤ 2 years (preterm, term, and infants). METHODS: Ten drugs were included in this study and administered intravenously: alfentanil, amikacin, busulfan, cefetamet, meperidine, oxycodone, propofol, sufentanil, theophylline, and tobramycin. These drugs were selected according to the availability of individual subjects' weight, age, and clearance data (concentration-time data for these drugs were not available to the author). The chosen drugs are eliminated by extensive metabolism by either the renal route or both the renal and hepatic routes. The six empirical models were (1) age and body weight-dependent sigmoidal maximum possible effect (Emax) maturation model, (2) body weight-dependent sigmoidal Emax model, (3) uridine 5'-diphospho [body weight-dependent allometric exponent model (BDE)], (4) age-dependent allometric exponent model (ADE), (5) a semi-physiological model, and (6) an allometric model developed from children aged > 2 years to adults. The model-predicted clearance values were compared with observed clearance values in an individual child. In this analysis, a prediction error of ≤ 50% for mean or individual clearance values was considered acceptable. RESULTS: Across all age groups and the ten drugs, data for 282 children were compared between observed and model-predicted clearance values. The validation data consisted of 33 observations (sum of different age groups for ten drugs). Only three of the six models (body weight-dependent sigmoidal Emax model, ADE, and semi-physiological model) provided reasonably accurate predictions of clearance (> 80% observation with ≤ 50% prediction error) in children aged ≤ 2 years. In most instances, individual predicted clearance values were erratic (as indicated by % error) and were not in agreement with the observed clearance values. CONCLUSIONS: The study indicated that simple empirical models can provide more accurate results than complex empirical models.

Qualitative exploration of women's experiences of intramuscular pethidine or remifentanil patient-controlled analgesia for labour pain.

OBJECTIVES: To explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum. DESIGN: Qualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken. SETTING: Women recruited to the RESPITE trial from seven UK hospitals. PARTICIPANTS: Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview. RESULTS: Eight themes emerged which encompassed women's antenatal plans for pain management (Birth Expectations) through to their future preferences for pain relief (Reflections for Future Choices). Many women who used remifentanil felt it provided effective pain relief (Effectiveness of Pain Relief), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea (Negative Physiological Responses) and women using remifentanil describing more cognitive effects (Cognitive Effects). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out (Issues with Drug Administration). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth (Enabling a Sense of Control). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups (Impact on Infant Behaviour and Breastfeeding). CONCLUSIONS: Qualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups. TRIAL REGISTRATION NUMBER: ISRCTN29654603.

The Influence of Adding Diphenhydramine Before Initiation of Moderate Sedation with Midazolam and Pethidine for Improving Quality of Colonoscopy.

BACKGROUND: Combination of Intravenous benzodiazepines with opiates appears to be essential in order to guarantee high quality of moderate sedation during colonoscopy. Diphenhydramine is recommended for endoscopic procedures in difficult-to-sedate patients However, the studies supporting its use have yielded conflicting results. OBJECTIVE: To assess the value of adding diphenhydramine hydrochloride before initiation of moderate sedation with midazolam and pethidine for Improving Quality of Sedation during colonoscopy. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled study of 150 Patients undergoing diagnostic colonoscopy. Of 150 patients, data were analyzed for 100 patients randomized into two groups: Diphenhydramine group (n = 53) received 50 mg of diphenhydramine intravenously before initiation of moderate sedation with pethidine and midazolam while in placebo group (n = 47) received placebo in addition to pethidine and midazolam. Amount of pethidine and midazolam used and Quality of sedation were assessed. RESULTS: The mean doses of pethidine was significantly higher in placebo group as compared to diphenhydramine group (69.9 ± 35.4 mg vs 61.2 ± 21.0 mg, p < 0.01) However, no significant difference between the two groups regarding midazolam mean dose (4.9.±2.1 mg vs 4.8 ± 2.0 mg,p = 0.786). More patients in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (88.67% vs 59.57%,p < 0.001).Furthermore more endoscopist in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (77.35% vs 51.06%,p < 0.001). CONCLUSIONS: Intravenous diphenhydramine hydrochloride given before initiation of midazolam and pethidine offers a significant Improvement of Quality of moderate Sedation during colonoscopy without increasing the number of sedation related complications.

Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT).

BACKGROUND: Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. METHODS: This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 µg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. RESULTS: Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. CONCLUSIONS: Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. TRIAL REGISTRATION: Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727 ; January 2018, "retrospectively registered".

Pelota de parto versus petidina y haloperidol en la satisfacción en el parto / Birthing ball versus pethidine and haloperidol in satisfaction with childbirth

Objetivo: Determinar los efectos en la satisfacción materna del uso de la pelota de parto como método de alivio del dolor, comparado con la administración subcutánea de petidina (50mg) y haloperidol (2,5mg), en el periodo de latencia de parto. Método: Ensayo clínico aleatorizado, unicéntrico, paralelo y controlado. Participantes: gestantes de bajo riesgo, ingresadas en la planta de embarazo patológico del HGU Gregorio Marañón, por gestación cronológicamente prolongada, rotura prematura de membranas o pródromos de parto. Intervención: una vez que la paciente manifestaba dolor con su proceso, se implementaban una serie de movimientos predeterminados con la pelota de partos, en el caso del grupo intervención, o se administraba petidina más haloperidol, vía subcutánea. Tras la intervención y en planta de puérperas la satisfacción era medida con la escala Mackey Satisfaction Childbirth, validada al castellano en 2016, en las primeras 48-72h posparto. Análisis: comparación de grupos: la t de Student para las variables continuas y la Chi-cuadrado para las categóricas. Resultados: La satisfacción materna fue significativamente mayor en el grupo experimental que en el grupo de comparación, en todas las esferas de la escala: obstetra (4,24/3,87), dilatación (4,02/3,35), expulsivo (4,27/3,67), recién nacido (4,72/4,43) y acompañamiento y comodidad (4,78/4,44). No hubo, sin embargo, diferencias estadísticamente significativas en la subescala matrona, aunque las puntuaciones fueron igualmente altas (4,65/4,45). Conclusión: El uso de pelotas de parto durante el periodo de latencia aumenta la satisfacción de la mujer en el proceso de parto, en mayor medida que la administración conjunta de petidina y haloperidol

Objective: To determine the effects on maternal satisfaction of the use of the birthing ball as a method of pain relief compared to the subcutaneous administration of pethidine (50mg) and haloperidol (2.5mg), during the latent phase of labour. Method: Randomised, unicentric, parallel and controlled clinical trial. Participants: Low-risk pregnant women hospitalised in a pathological pregnancy ward at the Gregorio Marañón University General Hospital (Madrid) due to prolonged pregnancy, premature rupture of membranes, or labour prodromes. Intervention: once the patient's labour had become painful, a series of pre-established movements were implemented with a birthing ball in the intervention group, or pethidine and haloperidol were administered at the same dose subcutaneously. After the intervention and on the post-natal ward, satisfaction was measured with the Mackey Satisfaction Childbirth scale, validated in Spanish in 2016, in the first 48-72hours after delivery. Analysis: group comparisons: Student's t for continuous variables and Chi-squared for categorical variables. Significance at p<0.05. Results: The maternal satisfaction was significantly higher in the experimental group than in the comparison group, in all the domains of the scale: obstetrician (4.24/3.87), dilatation (4.02/3.35), second stage (4.27/3.67), newborn (4.72/4.43), accompaniment and comfort (4.78/4.44). There were, however, no statistically significant differences in the midwife subscale, although the scores were equally high (4.65/4.45). Conclusion: Using birthing balls during the latent phase of labour increases women's satisfaction with their labour process more than administering pethidine and haloperidol during this period

Birthing ball versus pethidine and haloperidol in satisfaction with childbirth. / Pelota de parto versus petidina y haloperidol en la satisfacción en el parto.

OBJECTIVE: To determine the effects on maternal satisfaction of the use of the birthing ball as a method of pain relief compared to the subcutaneous administration of pethidine (50mg) and haloperidol (2.5mg), during the latent phase of labour. METHOD: Randomised, unicentric, parallel and controlled clinical trial. PARTICIPANTS: Low-risk pregnant women hospitalised in a pathological pregnancy ward at the Gregorio Marañón University General Hospital (Madrid) due to prolonged pregnancy, premature rupture of membranes, or labour prodromes. INTERVENTION: once the patient's labour had become painful, a series of pre-established movements were implemented with a birthing ball in the intervention group, or pethidine and haloperidol were administered at the same dose subcutaneously. After the intervention and on the post-natal ward, satisfaction was measured with the Mackey Satisfaction Childbirth scale, validated in Spanish in 2016, in the first 48-72hours after delivery. ANALYSIS: group comparisons: Student's t for continuous variables and Chi-squared for categorical variables. Significance at p<0.05. RESULTS: The maternal satisfaction was significantly higher in the experimental group than in the comparison group, in all the domains of the scale: obstetrician (4.24/3.87), dilatation (4.02/3.35), second stage (4.27/3.67), newborn (4.72/4.43), accompaniment and comfort (4.78/4.44). There were, however, no statistically significant differences in the midwife subscale, although the scores were equally high (4.65/4.45). CONCLUSION: Using birthing balls during the latent phase of labour increases women's satisfaction with their labour process more than administering pethidine and haloperidol during this period.

Pethidine in Low Doses versus Dipyrone for Pain Relief in Labor: A Randomized Controlled Trial.

OBJECTIVE: To compare low doses of pethidine with dipyrone in labor analgesia. METHODS: In a randomized prospective study conducted by Universidade de Fortaleza, in the state of Ceará, Brazil, between May and December 2016, 200 full-term parturients, with very painful uterine contractions and exhibiting uterine cervix dilatation ≥ 5 cm, were selected to receive a single intravenous dose of either 0.25 mg/kg of pethidine (n = 100) or of 25 mg/kg of dipyrone (n = 100). Pain was assessed using the visual analogue scale. The data were analyzed using the Student t-test, the chi-square test and the likelihood ratio. RESULTS: There was a significant improvement in pain in 35% of the parturients. Both drugs presented a similar analgesic effect 1 hour after the intervention (p = 0.692). There was no analgesic effect during the evaluation of the second hour after the intervention with pethidine or dipyrone. There were no adverse effects, such as maternal drowsiness, nausea or vomiting, related to the drugs used. CONCLUSION: Pethidine in low doses and dipyrone presented equivalent analgesia during labor. PUBLIC REGISTRY OF CLINICAL TRIALS: RBR-4hsyy4.

OBJETIVO: Comparar doses baixas de petidina com dipirona na analgesia de parto. MéTODOS: Em um estudo prospectivo randomizado realizado pela Universidade de Fortaleza, Ceará, Brasil, entre maio e dezembro de 2016, 200 parturientes a termo, com contrações uterinas muito dolorosas e apresentando dilatação do colo uterino ≥ 5 cm, foram selecionadas para receber dose única intravenosa de 0,25 mg/kg de petidina (n = 100) ou 25 mg/kg de dipirona (n = 100). A dor foi avaliada pela escala visual analógica. Os dados foram analisados por meio dos testes t de Student, qui-quadrado e razão de verossimilhança. RESULTADOS: Houve melhora significativa da dor em 35% das parturientes. Ambas as drogas apresentaram efeito analgésico semelhante 1 hora após a intervenção (p = 0.692). Inexistiu efeito analgésico durante a avaliação da segunda hora após a intervenção com a petidina ou com a dipirona. Não houve efeitos adversos, como sonolência, náuseas ou vômitos maternos, relacionados aos medicamentos utilizados. CONCLUSãO: A petidina em doses baixas e a dipirona apresentaram analgesia equivalente durante o trabalho de parto. REGISTRO PúBLICO DE TESTES CLíNICOS: RBR-4hsyy4.

Pethidine in low doses versus dipyrone for pain relief in labor: a randomized controlled trial / Petidina em doses baixas versus dipirona para alívio da dor no trabalho de parto: um ensaio clínico randomizado

Abstract Objective To compare low doses of pethidine with dipyrone in labor analgesia. Methods In a randomized prospective study conducted by Universidade de Fortaleza, in the state of Ceará, Brazil, between May and December 2016, 200 full-term parturients, with very painful uterine contractions and exhibiting uterine cervix dilatation ≥ 5 cm, were selected to receive a single intravenous dose of either 0.25 mg/kg of pethidine (n = 100) or of 25 mg/kg of dipyrone (n = 100). Pain was assessed using the visual analogue scale. The data were analyzed using the Student t-test, the chi-square test and the likelihood ratio. Results There was a significant improvement in pain in 35% of the parturients. Both drugs presented a similar analgesic effect 1 hour after the intervention (p = 0.692). There was no analgesic effect during the evaluation of the second hour after the intervention with pethidine or dipyrone. There were no adverse effects, such as maternal drowsiness, nausea or vomiting, related to the drugs used. Conclusion Pethidine in low doses and dipyrone presented equivalent analgesia during labor. Public Registry of Clinical TrialsRBR-4hsyy4.

Resumo Objetivo Comparar doses baixas de petidina com dipirona na analgesia de parto. Métodos Em um estudo prospectivo randomizado realizado pela Universidade de Fortaleza, Ceará, Brasil, entre maio e dezembro de 2016, 200 parturientes a termo, com contrações uterinas muito dolorosas e apresentando dilatação do colo uterino ≥ 5 cm, foram selecionadas para receber dose única intravenosa de 0,25 mg/kg de petidina (n = 100) ou 25 mg/kg de dipirona (n = 100). A dor foi avaliada pela escala visual analógica. Os dados foram analisados por meio dos testes t de Student, qui-quadrado e razão de verossimilhança. Resultados Houve melhora significativa da dor em 35% das parturientes. Ambas as drogas apresentaram efeito analgésico semelhante 1 hora após a intervenção (p = 0.692). Inexistiu efeito analgésico durante a avaliação da segunda hora após a intervenção com a petidina ou com a dipirona. Não houve efeitos adversos, como sonolência, náuseas ou vômitos maternos, relacionados aos medicamentos utilizados. Conclusão A petidina em doses baixas e a dipirona apresentaram analgesia equivalente durante o trabalho de parto. Registro público de testes clínicosRBR-4hsyy4.

The effects of novel α2-adrenoreceptor agonist dexmedetomidine on shivering in patients underwent caesarean section.

Objective: Meperidine used to control shivering during perioperative period has associated side effects. The present study compared the safety of selective α2-adrenoreceptor agonist dexmedetomidine and meperidine for anti-shivering in primiparas after caesarean delivery under combined spinal-epidural anesthesia (CSEA).Methods: 100 primiparas scheduled for caesarean delivery were randomly allocated to dexmedetomidine group (Group D, n=50) and meperidine positive control group (Group M, n=50). Primiparas experienced shivering that continued to cord clamping were treated with dexmedetomidine (0.5 µg/kg) or meperidine (0.5 mg/kg) after cord clamping. The primary outcome measures were incidence of nausea, vomiting, and respiratory depression. Secondary outcome measures were shivering score, vital signs including blood pressure, heart rate and O2 saturation, tympanic temperature, and sedation score.Results: Dexmedetomidine provided similar anti-shivering effects as meperidine in patients after caesarean delivery under CSEA, evidenced as all shivering primiparas responded to either dexmedetomidine or meperidine treatment within 15 min. However, incidence of nausea and vomiting were significantly lower after dexmedetomidine treatment, accompanied with more stable blood pressure. Dexmedetomidine also provided well regulation of tympanic temperature and good sedation.Conclusion: Selective α2-adrenoreceptor agonist dexmedetomidine has a better safety profile compared with meperidine for anti-shivering in primiparas undergoing caesarean delivery. Dexmedetomidine could be a better choice for anti-shivering in patients requiring caesarean section. The mechanism of anti-shivering for dexmedetomidine may relate to well regulation of temperature and good sedation.

Safety and efficacy of a combination of pethidine and levallorphan for pain relief during labor: An observational study.

AIM: To evaluate the safety, effect on breastfeeding and efficacy of a combination of pethidine and levallorphan (Pethilorfan) for pain relief during labor. METHODS: We compared maternal or neonatal morbidities, suckling difficulties in newborns and breastfeeding rates between 177 women who received 50-200 mg (as pethidine) of Pethilorfan during labor (Pethilorfan group) and 354 women who delivered their infants without analgesic drugs immediately before or after each woman in the Pethilorfan group (control group) from January 1, 2005 to December 31, 2016. We performed univariate and multivariate analyses for comparison between the two groups. We also evaluated the efficacy of Pethilorfan retrospectively. RESULTS: The Pethilorfan group included more women with prolonged and/or operative deliveries than the control group. Nevertheless, no significant differences were seen between the two groups in the rates of Apgar scores less than 7 at 1 or 5 min, composite neonatal morbidities, hyperbilirubinemia or respiratory disturbances. The incidence of suckling difficulties lasting over 24 h and the breastfeeding rates at discharge or after 1 month were also similar. Maternal adverse effects of Pethilorfan were generally mild and transient. The efficacy ratio of Pethilorfan was 83.6%, although its analgesic effect was usually incomplete. CONCLUSION: Pethilorfan can be used safely for labor pain relief without increasing maternal or neonatal morbidities, or impeding breastfeeding, if it is administered at a prudent dosage. Parenteral opioids including Pethilorfan should remain as an option for treating women in labor pain, particularly when epidural analgesia is not readily available or contraindicated.

Sedation of children undergoing dental treatment.

BACKGROUND: Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. This is the second update of the Cochrane Review first published in 2005 and previously updated in 2012. OBJECTIVES: To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 22 February 2018); MEDLINE Ovid (1946 to 22 February 2018); and Embase Ovid (1980 to 22 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. We excluded cross-over trials. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted, in duplicate, information regarding methods, participants, interventions, outcome measures and results. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. Cochrane statistical guidelines were followed. MAIN RESULTS: We included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I2 = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both. AUTHORS' CONCLUSIONS: There is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is a need for further well-designed and well-reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.

A Retrospective Study of Dosing Weight and Outcomes for One Pediatric Dental Sedation Regimen.

Purpose: The purpose of this study was to assess the use of a dosing scalar for association with the success of procedural sedation in pediatric dentistry. Methods: This cross-sectional, retrospective study assessed healthy two- to 12-year-olds who received an elixir of midazolam (0.3 mg/kg), meperidine (1.5 mg/kg), and hydroxyzine (1.0 mg/kg). The scaled body weight (SBW) for each patient was determined using the 50th percentile weight-for-age from the 2000 Centers for Disease Control and Prevention (CDC) growth chart. Children under the 50th percentile were dosed at their actual weight. Children weighing over the 50th percentile received a dose that was reduced to the 50th percentile weight-for-age. Statistical analysis evaluated sedation success, measured by the Houpt scale. Lean body weight (LBW) and ideal body weight (IBW) were calculated to compare SBW with other available dosing scalars. Results: The sample consisted of 427 children. The success was 73.8 percent. There was no significant difference in sedation success by dose delivered. The calculated LBW and IBW were significantly greater than the SBW (P<.001, P<.001). Conclusions: Sedation success was not affected by use of a scalar that reduced dosing weight to the 2000 CDC growth chart's 50th percentile weight-for-age.

Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial.

BACKGROUND: About a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental vaginal delivery. Remifentanil patient-controlled analgesia (PCA) in labour is an alternative to pethidine, but is not widely used. We aimed to evaluate epidural analgesia progression among women using remifentanil PCA compared with pethidine. METHODS: We did an open-label, multicentre, randomised controlled trial in 14 UK maternity units. We included women aged 16 years or older, beyond 37 weeks' gestation, in labour with a singleton cephalic presentation, and who requested opioid pain relief. We randomly assigned eligible participants (1:1) to either the intravenous remifentanil PCA group (40 µg bolus on demand with a 2 min lockout) or the intramuscular pethidine group (100 mg every 4 h, up to 400 mg in 24 h), using a web-based or telephone randomisation service with a minimisation algorithm for parity, maternal age, ethnicity, and mode of labour onset. Because of the differences in routes of drug administration, study participants and health-care providers were not masked to the group allocation. The primary outcome was the proportion of women who received epidural analgesia after enrolment for pain relief in labour. Primary analyses were unadjusted and analysed by the intention-to-treat principle. This study is registered with the ISRCTN registry, number ISRCTN29654603. FINDINGS: Between May 13, 2014, and Sept 2, 2016, 201 women were randomly assigned to the remifentanil PCA group and 200 to the pethidine group. One participant in the pethidine group withdrew consent, leaving 199 for analyses. The proportions of epidural conversion were 19% (39 of 201) in the remifentanil PCA group and 41% (81 of 199) in the pethidine group (risk ratio 0·48, 95% CI 0·34-0·66; p<0·0001). There were no serious adverse events or drug reactions directly attributable to either analgesic during the study. INTERPRETATION: Intravenous remifentanil PCA halved the proportion of epidural conversions compared with intramuscular pethidine. This finding challenges routine pethidine use as standard of care in labour. FUNDING: National Institute for Health Research Clinician Scientist Award.