Videolaryngoscopy versus Fiber-optic Intubation through a Supraglottic Airway in Children with a Difficult Airway: An Analysis from the Multicenter Pediatric Difficult Intubation Registry.

BACKGROUND: The success rates and related complications of various techniques for intubation in children with difficult airways remain unknown. The primary aim of this study is to compare the success rates of fiber-optic intubation via supraglottic airway to videolaryngoscopy in children with difficult airways. Our secondary aim is to compare the complication rates of these techniques. METHODS: Observational data were collected from 14 sites after management of difficult pediatric airways. Patient age, intubation technique, success per attempt, use of continuous ventilation, and complications were recorded for each case. First-attempt success and complications were compared in subjects managed with fiber-optic intubation via supraglottic airway and videolaryngoscopy. RESULTS: Fiber-optic intubation via supraglottic airway and videolaryngoscopy had similar first-attempt success rates (67 of 114, 59% vs. 404 of 786, 51%; odds ratio 1.35; 95% CI, 0.91 to 2.00; P = 0.16). In subjects less than 1 yr old, fiber-optic intubation via supraglottic airway was more successful on the first attempt than videolaryngoscopy (19 of 35, 54% vs. 79 of 220, 36%; odds ratio, 2.12; 95% CI, 1.04 to 4.31; P = 0.042). Complication rates were similar in the two groups (20 vs. 13%; P = 0.096). The incidence of hypoxemia was lower when continuous ventilation through the supraglottic airway was used throughout the fiber-optic intubation attempt. CONCLUSIONS: In this nonrandomized study, first-attempt success rates were similar for fiber-optic intubation via supraglottic airway and videolaryngoscopy. Fiber-optic intubation via supraglottic airway is associated with higher first-attempt success than videolaryngoscopy in infants with difficult airways. Continuous ventilation through the supraglottic airway during fiber-optic intubation attempts may lower the incidence of hypoxemia.

A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients.

BACKGROUND: Oral antipyretics are commonly used to treat pediatric patients who develop fevers. However, patients presenting to the emergency department or undergoing surgery are frequently unable to tolerate oral antipyretics. Rectal formulations are available; however, this route of administration is unpredictable. The main objectives of this randomized controlled study was to evaluate the efficacy and safety of single or multiple doses of intravenous ibuprofen to acetaminophen (oral or suppository) in pediatric patients with fever and to assess plasma ibuprofen concentrations. METHODS: This multi-center study was conducted in hospitalized patients, ≤ 16 years, with a new onset of fever ≥ 38.3°C. Patients were randomly assigned to receive either 10 mg/kg intravenous ibuprofen or acetaminophen. Study drug was administered at hour 0, and thereafter every 4 h as needed, up to 5 days. The primary outcome was to evaluate the effect of a single dose of intravenous ibuprofen compared to acetaminophen in reducing temperature in the first 2 h after administration. Data were compared using an analysis of variance model for continuous measurements and Cochran-Mantel-Haenszel test of general association for categorical data. A two-sided testing was used and a p-value ≤ 0.05 was considered significant. RESULTS: A total of 103 patients received study medication. Intravenous ibuprofen resulted in a greater reduction in temperature as measured by the area under the change from baseline at 2 h (p = 0.005) and 4 h (<0.001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period. There were no differences in safety parameters or serious adverse events. CONCLUSIONS: A single 10 mg/kg dose of intravenous ibuprofen provided a significant reduction of temperature for febrile pediatric patients compared to those that received 10 mg/kg acetaminophen at 2 h and 4 h post-treatment. A reduction in temperature was also demonstrated over 24 h; however the reduction was not considered statically significant. Intravenous ibuprofen provides an effective option for reducing fever in hospitalized pediatric patients. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov on 26 October 2009, Study Identifier: NCT01002573.

Harmonization of description and classification of fetal observations: achievements and problems still unresolved: report of the 7th Workshop on the Terminology in Developmental Toxicology Berlin, 4-6 May 2011.

This article summarizes the 7th Workshop on the Terminology in Developmental Toxicology held in Berlin, May 4-6, 2011. The series of Berlin Workshops has been mainly concerned with the harmonization of terminology and classification of fetal anomalies in developmental toxicity studies. The main topics of the 7th Workshop were knowledge on the fate of anomalies after birth, use of Version 2 terminology for maternal-fetal observations and non-routinely used species, reclassification of "grey zone" anomalies and categorization of fetal observations for human health risk assessment. The paucity of data on health consequences of the postnatal permanence of fetal anomalies is relevant and further studies are needed. The Version 2 terminology is an important step forward and the terms listed in this glossary are considered also to be appropriate for most observations in non-routinely used species. Continuation of the Berlin Workshops was recommended. Topics suggested for the next Workshop were grouping of fetal observations for reporting and statistical analysis.

Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways.

BACKGROUND: We sought to characterize the airway responses to desflurane during maintenance of and emergence from anesthesia in children whose airways were supported with laryngeal mask airways (LMAs). METHODS/MATERIALS: Four hundred healthy children were randomized in a 3 : 1 ratio to either desflurane or isoflurane (reference group) during anesthetic maintenance. After induction of anesthesia, anesthesia was maintained with the designated anesthetic. The investigator chose the airway (LMA and facemask), ventilation strategy and when to remove the LMA. The incidence of airway events during maintenance, emergence and recovery was recorded. RESULTS: Ninety percent of children received LMAs. The frequency of major airway events after desflurane (9%) was similar to that after isoflurane (4%) (number needed to harm [NNH] 20), although the frequency of major events after the LMA was removed during deep desflurane anesthesia (15%) was greater than during awake removal (5%) (NNH 10) (P < 0.006) and during deep isoflurane removal (2%) (NNH 8) (P < 0.03). The frequency of airway events of any severity after desflurane was greater than that after isoflurane (39% vs 27%) (P < 0.05). The frequencies of laryngospasm and coughing of any severity after desflurane were greater than those after isoflurane (13% vs 5% and 26% vs 14%, respectively) (P < 0.05). CONCLUSIONS: When an LMA is used during desflurane anesthesia in children, fewer airway events occur when it is removed when the child is awake. Although the time to discharge from recovery was not delayed and no child required overnight admission, caution should be exercised when using an LMA in children who are anesthetized with desflurane.

Presurgical fentanyl vs caudal block and the incidence of adverse respiratory events in children after orchidopexy.

BACKGROUND: There is controversy about the etiology of early postoperative hypoxemia. Age, weight, intubation, surgical procedure, use of muscle relaxants, and/or administration of opioids may affect the incidence of early postoperative hypoxemia. In this prospective, randomized, and single-blinded study, we evaluated whether the administration of caudal analgesia vs i.v. fentanyl affected the number of children who develop postextubation adverse upper airway respiratory events, (upper airway obstruction, laryngospasm) and/or early postoperative hypoxemia. METHODS/MATERIALS: Institutional approval and written parental informed consents were obtained. Thirty-eight healthy outpatient boys, aged 1-6 years, scheduled for elective orchidopexy were randomized to receive pain relief either with a presurgical caudal block or by i.v. fentanyl. The primary outcome of the study was the number of children who developed postextubation adverse upper airway respiratory events and/or early postoperative hypoxemia. RESULTS: The number of boys who developed postextubation adverse upper airway respiratory events and/or early postoperative hypoxemia in the caudal group was less compared with those in the fentanyl group (P = 0.04). CONCLUSIONS: Compared to fentanyl, placement of a presurgical caudal block in boys scheduled for orchidopexy was associated with a lower incidence of postextubation adverse upper airway respiratory events and/or early postoperative hypoxemia.

Caffeine in children with obstructive sleep apnea.

BACKGROUND: Children with obstructive sleep apnea (OSA) have a higher rate of adverse post-extubation respiratory events, such as laryngospasm, upper airway obstruction, apnea, desaturation and/or need for re-intubation. They are overly sensitive to sedatives and narcotics. Although the etiology of OSA is primarily obstruction (mechanical or neuromuscular), a central element may contribute to OSA. Caffeine citrate has been shown to be effective in treating apnea of prematurity. This study evaluated whether the administration of caffeine benzoate to children with OSA decreases the number of children who experience adverse post-extubation respiratory events. METHODS: In a randomized, double-blind and placebo-controlled study, children with OSA scheduled for adenotonsillectomy (T&A) received either caffeine benzoate, 20 mg/kg IV, (caffeine group, n = 36) or saline (placebo group, n = 36). The primary outcome evaluated the number of children who developed adverse post-extubation respiratory events, and the secondary outcome was the incidence of those events. RESULTS: The results demonstrated the two groups differed in the number of children who developed adverse post-extubation respiratory events (p = 0.032). The overall incidence of adverse postoperative respiratory events was less in the caffeine group than the placebo group (p = 0.0196). CONCLUSION: In children with OSA scheduled for T&A, administration of caffeine benzoate, 20 mg/kg IV, decreased the number of children who developed adverse post-extubation respiratory events and decreased the overall incidence of adverse post-extubation respiratory events. PACU duration, hospital discharge time and postoperative delirium did not differ between groups.

Caudal regional anesthesia, ropivacaine concentration, postoperative analgesia, and infants.

In this randomized, double-blind trial we evaluated the quality and duration of analgesia and motor effects after caudal block using 1 mL/kg of ropivacaine 0.1% (Group 1), 0.15% (Group 2), 0.175% (Group 3) compared to 0.2% (Group 4) in infants 1-12 mo old. Postoperatively, the number of infants who received pain medication differed among the groups (P < 0.0005). There were more infants in Groups 1 and 2 compared with Group 4 and there was no difference between Groups 3 and 4. In the postanesthesia care unit, infants in Groups 1 and 2 received more pain medication than did those in Group 4 (P = 0.0098). In the day surgery unit, there was a significant difference among the groups (P = 0.0326); infants in Groups 3 and 4 required no pain medication. The analgesia duration differed among the groups (P = 0.034). Infants in Groups 1 and 2 had a shorter duration, and there was no difference between Groups 3 and 4. Infants in Group 4 took longer to regain their motor power compared with those in Group 3 (P = 0.0347). We conclude that in infants, ropivacaine 0.175% provided postoperative analgesia and duration similar to that of ropivacaine 0.2%, whereas ropivacaine 0.1% and 0.15% did not, and it was associated with fewer motor effects.

A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia.

UNLABELLED: We assessed the efficacy and safety of ondansetron (0.1 mg/kg IV) prophylactically administered before surgery for prevention of postoperative vomiting (POV) in a double-blind, placebo-controlled study of 670 pediatric patients, 1- to 24-mo-old, undergoing elective surgery under general anesthesia. The study enrolled 335 children in each treatment group (ondansetron versus placebo). Significantly fewer children treated with ondansetron exhibited emesis or discontinued the study prematurely after surgery (ondansetron, 11%; placebo, 28%; odds ratio = 0.33; P < 0.0001). The number required to treat prophylactically with ondansetron to prevent POV was approximately six. Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21). The incidence of POV and other antiemetic effects of ondansetron were similar in children aged 1-12 mo and 13-24 mo and in children prospectively expected or not expected to require opioids as part of their anesthetic or analgesic management. Ondansetron was well tolerated; the incidence of adverse events considered possibly related to study drug was similar between treatment groups (ondansetron, 1.8%; placebo, 1.5%). IMPLICATIONS: This prospective, randomized, double-blind, placebo-controlled study establishes the efficacy and tolerability of IV ondansetron (0.1 mg/kg) in the prevention of postoperative emesis in 1- to 24-mo-old pediatric patients undergoing elective surgery under general anesthesia.

Regional analgesia combined with avoidance of narcotics may reduce the incidence of postoperative vomiting in children.

BACKGROUND: The anesthesia literature cites a high incidence of postoperative vomiting (POV) after pediatric ochidopexy and hernia repair (34-50%) and after penile procedures (37-49%). We hypothesized that regional analgesia combined with avoidance of narcotics administered to children scheduled for lower abdominal or urologic procedures may be associated with a lower incidence of POV. The aim of this prospective study was to 1) assess the incidence of POV in children in the hospital and during a 24-h post-anesthesia study period, and 2) evaluate the effect of age on POV. METHODS: After obtaining institutional and parental consent, 110 pediatric outpatients, 1-12 yr old, ASA physical status I or II, scheduled for elective outpatient urologic or lower abdominal procedures, were enrolled. Children were fasting and premedicated with midazolam, 0.5 mg/kg p.o. They received a combined light general anesthesia and a presurgical caudal block. Anesthesia was induced via a mask and consisted of halothane and nitrous oxide in oxygen. For the caudal block 1 ml/kg of 0.25% bupivacaine or 0.2% ropivacaine were used to provide intra- and postoperative pain relief. No prophylactic antiemetics were administered. RESULTS: All caudal blocks provided adequate intraoperative pain relief. The incidence of POV was low, 12% at the hospital, 13% for the 24-h study period, and was not affected by age. CONCLUSIONS: We concluded that regional analgesia combined with the avoidance of narcotics administered to children scheduled for elective urologic or lower abdominal procedures, is associated with a lower incidence of POV and that age did not affect the incidence of POV.

Presurgical caudal block attenuates stress response in children.

BACKGROUND: Our aim was to determine if the anesthesia technique for pain relief in children affects the stress response after minor surgery. A rise in blood glucose reflects stress-related effects in children who do not receive glucose perioperatively. METHODS: Twenty-eight children, ages 17-81 mos, undergoing elective urologic procedures, were enrolled. For pain relief, patients received presurgical caudal block (group 1), intravenous narcotics (group 2), or postsurgical caudal block (group 3). Blood samples were analyzed for glucose concentrations immediately after induction of anesthesia at baseline, 15 min after surgical incision (second sample), and 30 min after end of surgery (third sample). RESULTS: In group 1 there was no change in glucose concentration in the second or third samples compared to baseline, while in group 3 there were significant increases in those samples, and in group 2 there was a significant increase in the second sample compared to baseline. Children in group 1 required significantly fewer narcotics in the postanesthesia care unit (PACU), and those in group 2 had significantly longer PACU and hospital durations. CONCLUSIONS: Presurgical caudal analgesia attenuates the stress response of anesthesia and surgery and decreases postoperative narcotic use while narcotics prolong PACU and discharge times.

Harmonization of rat fetal external and visceral terminology and classification. Report of the Fourth Workshop on the Terminology in Developmental Toxicology, Berlin, 18-20 April 2002.

This article is a report on the Fourth Berlin Workshop on Terminology in Developmental Toxicology, which was held in April 2002. The workshop is part of an international project in the field of harmonization of terminology in developmental toxicology supported by IPCS. The goal of the Harmonization Project is to ensure better chemical risk assessment. The aim of this Fourth Workshop was to discuss the results of a previously conducted survey on classification of external and visceral anomalies, which are listed in the international glossary, developed under the auspices of IFTS (1997 glossary). The discussions among experts from research institutions, regulatory agencies, and industries were mainly focussed on terms for which there was disagreement and/or uncertainties and the possible reasons. For the illustration of "gray-zone" anomalies, pictures were provided by the participants, which constituted the basis for detailed discussions. There was high agreement that most of the external anomalies (>66%) should be classified as malformations. The few external anomalies for which there was low agreement to classify as a malformation were discussed in detail. None of the external findings, which had in the survey a high agreement, were categorized as a variation.A high agreement regarding the classification of approximately one-third of visceral anomalies was achieved with 34 and 2% being described as malformation and variation, respectively. Most of the visceral findings had low agreement indices and there appeared to be several reasons for this. Thus, the response, 'Not known/not used in the laboratory' (N) was often given. A couple of reasons for difficulties in the classification of an anomaly were that it is only rarely seen upon fetal examination or tends to be species specific. Furthermore, the classification of some anomalies as malformation or variation will remain vague as the decision must be made on a case-by-case basis. Factors affecting the decision include: the availability of appropriate historical control data, description of the grading and severity, whether the anomaly occurs in isolation or whether there is a relationship with an abnormal process, and finally, if the change represents an irreversible one, affecting human and/or animal health. It was concluded that a severity grading, supported by pictures of the anomaly, would be especially helpful to classify certain changes as malformation or as variation. Several of the soft tissue changes were considered likely to be the consequence of functional disorders and thus not strictly developmental anomalies. The possibility to describe a finding as 'Not Malformation' (Unclassified) was agreed upon. As a general conclusion it was emphasized that the observation of a permanent structural change should be considered to be a warning of possible consequences to humans, even when there is no apparent adverse effect on health and survival in adult animals of the species under investigation. Therefore, research is needed to further investigate postnatal consequences. Future collaboration in the field of reproductive and developmental toxicology should aim to further develop and implement a harmonized approach to the interpretation of study data. Therefore, this terminology work will continue in close cooperation with the IPCS Harmonization Project. A Steering Group should be established to facilitate the implementation of harmonized terminology into daily scientific work and its regulatory application.

A paediatric trial comparing midazolam/Syrpalta mixture with premixed midazolam syrup (Roche).

BACKGROUND: The bitter taste of midazolam is more acceptable to children when the drug is mixed with fruit juice or syrup. We use a thick grape syrup (Syrpalta), and children are sedated in 10-15 min. A premixed cherry-flavoured midazolam solution (Roche), 2 mg.ml (-1), is currently available. It has been our impression that the premixed midazolam has a slower onset of action. Our aim was to evaluate the effects of the midazolam mixtures (midazolam 0.5 mg.kg (-1), 2 mg.ml (-1)) on children's anxiety, sedation, separation anxiety, mask acceptance, and recovery time. METHODS: Seventy-six healthy children, 1-4 years of age, scheduled for elective placement of ear tubes, were enrolled. The trial was double-blinded and randomized. For premedication, one group received the premixed midazolam, and a second group received the midazolam/Syrpalta mixture. An independent blinded observer evaluated the children, using anxiety and sedation scales at baseline, at 5, 10 and 15 min and at parental separation. Mask acceptance and awakening time were evaluated. RESULTS: Children who received the midazolam/Syrpalta mixture had less anxiety at 15 min (P = 0.046) and at parental separation (P < 0.001) than those who received the premixed midazolam solution. Mask acceptance was not different. CONCLUSIONS: We concluded that the midazolam/Syrpalta mixture has a faster onset of action than the premixed midazolam solution.