An international multidisciplinary consensus statement on fasting before procedural sedation in adults and children.

The multidisciplinary International Committee for the Advancement of Procedural Sedation presents the first fasting and aspiration prevention recommendations specific to procedural sedation, based on an extensive review of the literature. These were developed using Delphi methodology and assessment of the robustness of the available evidence. The literature evidence is clear that fasting, as currently practiced, often substantially exceeds recommended time thresholds and has known adverse consequences, for example, irritability, dehydration and hypoglycaemia. Fasting does not guarantee an empty stomach, and there is no observed association between aspiration and compliance with common fasting guidelines. The probability of clinically important aspiration during procedural sedation is negligible. In the post-1984 literature there are no published reports of aspiration-associated mortality in children, no reports of death in healthy adults (ASA physical status 1 or 2) and just nine reported deaths in adults of ASA physical status 3 or above. Current concerns about aspiration are out of proportion to the actual risk. Given the lower observed frequency of aspiration and mortality than during general anaesthesia, and the theoretical basis for assuming a lesser risk, fasting strategies in procedural sedation can reasonably be less restrictive. We present a consensus-derived algorithm in which each patient is first risk-stratified during their pre-sedation assessment, using evidence-based factors relating to patient characteristics, comorbidities, the nature of the procedure and the nature of the anticipated sedation technique. Graded fasting precautions for liquids and solids are then recommended for elective procedures based upon this categorisation of negligible, mild or moderate aspiration risk. This consensus statement can serve as a resource to practitioners and policymakers who perform and oversee procedural sedation in patients of all ages, worldwide.

Paradoxical reactions to rectal midazolam as premedication in children.

Eighty healthy children, between the ages of 2 and 7 years, who were to undergo oral surgical procedures under general anaesthesia, were allocated randomly to 4 groups. Three groups received rectal midazolam, and the other group a placebo (saline) as premedication 30 min prior to induction of anaesthesia. Group A children received midazolam 0.25 mg/kg, Group B 0.35 mg/kg and Group C 0.45 mg/kg. No statistically significant difference was found between the treatment groups as to the effect on systolic- (p = 0.6920) and diastolic (p = 0.8701) blood pressures, respiration (p = 0.0505) and pulse (p = 0.6192) rates at either pre- or post-sedation levels. However, the results indicate that levels of anxiolysis and sedation were significantly associated with midazolam dosage (p less than 0.0001).

Intravenous midazolam in oral surgery.

Intravenously administered midazolam (0.1 mg/kg) was compared with placebo in a randomized study in 50 patients undergoing oral surgical procedures under local anaesthesia. The results obtained from this study showed that midazolam when compared to placebo had slight cardiovascular and respiratory depressant effects, diminished anxiety and caused amnesia. It also provided better operating conditions and possibly stimulated appetite.

Oxygen desaturation in a child receiving a combination of ketamine and midazolam for dental extractions.

A combination of 0.35 mg/kg midazolam and 5 mg/kg ketamine, administered orally for pediatric sedation, resulted in a severe decreases in blood oxygen saturation postoperatively. The patient, a 2-yr-old child, did not respond to command or mild physical stimulation in the recovery room 60 min after receiving the drugs. The benzodiazepine antagonist, flumazenil (0.01 mg/kg), was administered intravenously to reverse the action of midazolam. No adverse effects were observed thereafter, and the postoperative recovery was uneventful. Combining different classes of drugs may result in less variability in patients response, but there is a greater potential for drug-induced side effects and drug interactions.

Total intravenous anesthesia with propofol for thymectomy in a patient with myasthenia gravis.

Experience with the use of propofol for induction and maintenance of anesthesia in patients with myasthenia gravis is limited. This case report documents the safe use of propofol in a patient with myasthenia gravis. Because of its unique pharmacodynamic and pharmacokinetic profile, propofol may be an ideal agent for safe use in the young patient with myasthenia gravis.

Serum potassium after enflurane-succinylcholine induction of anesthesia in children receiving rectal midazolam as premedication.

The administration of succinylcholine causes an increase in serum potassium (K+) concentrations in healthy patients. The purpose of this study was to investigate serum K+ changes following intravenous succinylcholine in children and to evaluate the effect of rectal midazolam pretreatment on these changes. Forty healthy children between the ages of 2 and 7 yr, and who were to undergo oral surgical procedures under general anesthesia were randomly assigned to receive either placebo (saline) or 0.25, 0.35, or 0.45 mg/kg midazolam administered rectally as premedication 30 min before induction of inhalational anesthesia. Blood was drawn after induction with enflurane and at 1, 2, 3, 4, and 5 min after administration of 1 mg/kg succinylcholine to determine changes in serum K+. Although the results indicate a significant increase in serum K+ after succinylcholine in all groups, midazolam pretreatment failed to cause any observable attenuation in the hyperkalemic response.

Tramadol drops in children: analgesic efficacy, lack of respiratory effects, and normal recovery times.

Tramadol hydrochloride is a racemic mixture of two enantiomers. It has analgesic activity suitable for mild to moderate pain, part of its analgesic activity being modulated via mu receptors. Adult studies have raised the question of increased electroencephalographic activity. The study examined the analgesic efficacy, respiratory effects, and behavior plus recovery-influencing properties of tramadol in the pediatric patient. Day-case dental extraction children, aged 4-7 years having 6 or more extractions, were studied. Tramadol drops, 3 mg/kg, plus oral midazolam, 0.5 mg/kg, were administered 30 minutes prior to a sevoflurane in N2O and O2 anesthetic. Forty children received this premedication treatment (T) and 10 entered a placebo control group (P), where no tramadol was administered. Entry was random, double blind, and parallel. Analgesic efficacy was measured using the Oucher face pain scale (OFPS), with responders scoring three or less. Respiration was measured by rate and oxygen saturation. Behavior and ease of mask induction were assessed on a 4-point scale. Recovery was measured with the Aldrete scale. Parameters were measured from 30 minute preanesthetic to 120 minute postanesthetic. Analgesic efficacy was shown, with an OFPS score of 11.42 (SD 18.66) (T) and 29.80 (SD 25.14) (P) (P < .05). Responders on tramadol were 77.5% versus 0% on placebo (P < .05). No respiratory depression was seen; rates and oxygen saturations were the same preanesthetic and postanesthetic. Similarly, the two groups had no cardiovascular differences. Preanesthetic behavior patterns were the same (P > .05), with 85% of the tramadol group being drowsy but awake versus 90% in the placebo group. Similarly satisfactory induction behavior was seen in 95% of the tramadol group and 90% of the placebo group. Recovery times were 48.6 minutes (SD 32.3) (T) and 43.1 minutes (SD 32.5) (P) (P > .05). It is concluded that tramadol at 3 mg/kg has no clinical respiratory depressant effect and that behavior and recovery times are unaffected. Analgesic efficacy is demonstrated.

Anesthetic management of a patient with Bartter's syndrome undergoing orthognathic surgery.

Bartter's syndrome is a rare disorder characterized by severe hypokalemic alkalosis, marked elevation in plasma renin activity, pressor insensitivity to angiotensin II, and normal or low values of plasma sodium, plasma chloride, and blood pressure. Many of the clinical features and biochemical abnormalities appear to be secondary to chronic hypokalemia. We managed a 22-yr-old man requiring orthognathic surgery for correction of facial asymmetry under general anesthesia.

Propofol for sedation in a mentally retarded dental patient.

A 21-yr-old mentally retarded and cardiovascularly compromised woman who required dental restorative work and extractions was admitted to our clinic. We had previously successfully sedated her with propofol and midazolam. In this case she was sedated with a 1% propofol solution administered initially at a rate of 8 mg/kg-hr. After 5 min, the infusion rate was lowered to 5 mg/kg-hr, and after the local anesthetic injection, was adjusted to 3 mg/kg-hr. After 15 min, the patient became restless, and the propofol infusion rate was again increased to 5 mg/kg-hr. The patient's airway was well maintained during the entire procedure; she remained well sedated, and no adverse effects were experienced.

Propofol and midazolam for conscious sedation in a mentally retarded dental patient.

Conscious sedation was provided for a 21-yr-old mentally retarded and cardiovascularly compromised women who required dental extractions, by initially infusing propofol (3 mg/kg/hr), augmented with a bolus dose of intravenous midazolam (1 mg). After 45 min the propofol infusion rate was reduced to 1 mg/kg/hr. The patient remained well-sedated during the entire procedure and no adverse effects were experienced.

An anaphylactic reaction to protamine sulfate.

Presented is a case in which protamine sulfate administration caused an immediate allergic-like reaction. The patient, a 50-year-old woman, had received protamine previously to reverse the anticoagulant effect of heparin after open heart surgery. In a similar operation 7 years later, protamine was used again for the same reason. Immediately following intravenous infusion of 3 mg/kg protamine sulfate, a sudden drop of the mean arterial blood pressure to 40 mm Hg occurred, and the heart rate increased from 100 to 130 beats/min. Severe angioneurotic edema of the face and trunk also developed. The reaction was successfully treated with vasopressors, steroids, and volume expansion. Subsequent skin testing revealed a positive reaction to protamine sulfate.

Arterial oxygen saturation in children receiving rectal midazolam as premedication for oral surgical procedures.

Eighty healthy children, between the ages of 2 and 7 years, undergoing dental procedures were monitored with a pulse oximeter for changes in arterial oxygen saturation. The children were randomly allocated into 4 groups in this double-blind study. Three groups received rectal midazolam, and the other group a placebo (saline) as premedication 30 min prior to induction of anesthesia. Group A children received midazolam 0.25 mg/kg, Group B 0.35 mg/kg and Group C 0.45 mg/kg. The results from this trial show no statistical significant difference between the treatment groups as to the effect on either systolic or diastolic blood pressure, respiration, or pulse rates at either pre- or post-sedation levels. However, the oxygen saturation levels for groups B and C differed significantly from those of the placebo groups 30 minutes after premedication (P = 0.0259).

Pharmacokinetics of oral tramadol drops for postoperative pain relief in children aged 4 to 7 years--a pilot study.

Tramadol hydrochloride is an analgesic with mu receptor activity suitable for administration to children as oral drops. As the serum concentration profile and pharmacokinetic parameters in young children are not known via this route, we studied 24 healthy ASA 1 children to determine those parameters. The children's mean age was 5.3 +/- 1.1 years and their mean weight was 17.8 +/- 3.1 kg. They underwent general anesthesia with sevoflurane for dental surgery. The mean duration of anesthesia was 27.9 +/- 10.1 minutes. Tramadol 1.5 mg/kg (this dose was chosen because we have previously shown it to be effective in providing analgesia following pediatric dental surgery) was administered as oral drops 30 minutes before anesthesia. Venous blood samples were taken following the tramadol at 30-minute intervals for 4 hours, every 2 hours for 6 hours, and every 4 hours for 12 hours. The samples were centrifuged and the serum stored at -20 degrees C, and nonstereoselective gas chromatography was used to determine the concentration of (+) and (-) tramadol enantiomers plus their o-demethyltramadol (M1) metabolite concentrations. The tramadol absorption was rapid, the maximum measured serum concentration present occurring before the first sample at 30 minutes. That first sample had a concentration of 352 +/- 83.4 ng/mL. The concentration remained above the 100 ng/mL analgesic level until 6.8 +/- 0.9 hours. The elimination half-life was 3.6 +/- 1.1 hours, the serum clearance 5.6 +/- 2.7 mL/kg/min, and the volume of distribution 4.1 +/- 1.2 L/kg. The (+) enantiomer concentration was 14.2 +/- 4.9% greater than that of the (-) enantiomer. The M1 metabolites had a (-) enantiomer concentration 92.3 +/- 75.1% greater than the (+) enantiomer. From the peak concentration at 4.5 +/- 1.5 hours, the concentration of the metabolite was approximately one third that of the parent drug. The M1 elimination half-life was 5.8 +/- 1.7 hours. Apart from the rapid rise in the serum concentration, these kinetic parameters are similar to those seen in healthy young adults. The concentration profile supports an effective clinical duration in the region of 7 hours.

An evaluation of analgesic efficacy and clinical acceptability of intravenous tramadol as an adjunct to propofol sedation for third molar surgery.

This article details a double-blind, randomized, placebo-controlled pilot study evaluating the analgesic efficacy and clinical acceptability of intravenous tramadol in patients undergoing surgical removal of an impacted third molar tooth under local anesthesia and intravenous sedation with propofol. Forty-five ASA status 1 dental outpatients were randomly allocated to 2 groups of 22 (group A) and 23 (group B) patients each (n = 45). Group A (T/P) received intravenous tramadol 1.5 mg/kg injected over 2 minutes, followed by a bolus dose of intravenous propofol 0.4 mg/ kg. Maintenance consisted of a continuous infusion of propofol 3 mg/kg/h, with an additional bolus dose of 0.4 mg/kg intravenously 2-3 minutes prior to the infiltration of the local anesthetic solution. Group B (P/P) patients received no tramadol but instead a saline placebo solution and an identical amount of propofol. Overall, in this study, postoperative pain was much better controlled in the group receiving tramadol 1.5 mg/kg intravenously despite there being no significant difference in the dose of propofol administered in both groups. Intravenous tramadol, when given with propofol, did not affect the cardiovascular, respiratory, and sedative effects of propofol. Following tramadol, despite being an opioid, no nausea and vomiting were reported in the early postoperative period, indicating the value of using tramadol with propofol. Thus, this pilot study demonstrated the potential use of intravenous tramadol with propofol in day-case dento-alveolar surgery.

Analgesic and anti-inflammatory efficacy of tenoxicam and diclofenac sodium after third molar surgery.

Tenoxicam and diclofenac sodium were compared with each other for analgesic efficacy following removal of third molars under general anesthesia. Thirty-five healthy patients between the ages of 18 and 28 yr were randomly allocated to two groups to participate in this study. Patients in Group A (n = 17) received a single intravenous injection of tenoxicam 40 mg at induction of anesthesia, followed by a 20-mg tablet given in the evening of the day of the operation and thereafter, one 20-mg tablet daily from days 2 to 7. Group B (n = 18) received a single intramuscular injection of diclofenac sodium 75 mg at induction of anesthesia, followed by a 50-mg tablet 4 to 6 hr after the operation and again, between 2100 hr and 2200 hr the same day. Thereafter, a 50-mg tablet was taken 3 times daily for the next 6 days. Pain was measured hourly for the first 4 hr postoperatively, then at 21 hr, and thereafter in the morning and the evenings on days 2 to 7. The highest pain scores were obtained 1 hr postoperatively for both trial groups. At 1 and 2 hr postoperatively, no statistical significant differences in pain scores could be shown for both groups. However, at 3 and 4 hr postoperatively, patients in the tenoxicam group experienced significantly (P < or = 0.05) less pain than those in the diclofenac sodium group. On the evening of the third postoperative day, the tenoxicam group of patients experienced significantly less pain (P < or = 0.05) than those in the diclofenac sodium group. This was again the case on the morning of the fourth postoperative day. On the fifth, sixth, and seventh postoperative days, the average pain scores for patients in the tenoxicam group were statistically significantly lower, both mornings and evenings, than those in the diclofenac sodium group of patients (P = 0.05).

A double blind randomized comparison of oral trimeprazine-methadone and ketamine-midazolam for sedation of pediatric dental patients for oral surgical procedures.

The safety and efficacy of an oral sedation technique for children having minor oral surgical procedures under local anesthesia were studied. One hundred healthy children between the ages of 2 and 7 yr received either a combination of midazolam (0.35 mg/kg) and ketamine (5 mg/kg) (Group A), or a combination of trimeprazine (3 mg/kg) and methadone (0.2 mg/kg) (Group B) 30 min preoperatively. Hemodynamic parameters, adverse reactions, postoperative recovery, and behavior were evaluated. More children were asleep, but rousable to verbal commands, 30 min after drug administration in Group A (40%) than in Group B (8%). Immediately before the dental procedure, 46% of children in Group A were asleep in contrast to 8% of children in group B. Significantly more children in Group A were awake, coughing, crying, and moving purposefully 30 and 60 min after admission to the recovery room. Two children (4%) in Group A vomited. Ten (20%) children in Group A hallucinated compared to none in Group B. The surgeon rated the procedure as good or very good in 94% of children in Group A compared to 78% in Group B. Our results show that the combination of midazolam and ketamine, administered orally, is a safe, effective, and practical approach to managing children for minor oral surgical procedures under local anesthesia.

Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison.

This article details a double-blind, randomized study evaluating the efficacy and safety of intranasal sufentanil and intranasal midazolam (S/M) when compared with intranasal ketamine and intranasal midazolam (K/M) for sedation and analgesia in pediatric patients undergoing dental surgery. Fifty healthy ASA status 1 children aged 5-7 years, weighing 15-20 kg, and having 6 or more teeth extracted, were randomly allocated to 2 groups of 25 patients each (n = 50). In the S/M group, 25 children received intranasal sufentanil 20 microg, and intranasal midazolam 0.3 mg/kg 20 minutes before the induction of anesthesia. In the K/M group, 25 children received intranasal ketamine 5 mg/kg and intranasal midazolam 0.3 mg/kg 20 minutes before the induction of anesthesia. Sevoflurane in nitrous oxide and oxygen was used for induction and maintenance of anesthesia. This study demonstrated the safety and efficacy of both methods with ease of administration, combined with a rapid onset of action. Both groups were equally sedated. A smooth mask induction of anesthesia was experienced in the majority of children. Effective postoperative analgesia for multiple dental extractions was provided. The intranasal administration of drugs for sedation and analgesia has some promising features in preschool children undergoing multiple dental extractions.