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.

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.

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.

Oral tramadol: analgesic efficacy in children following multiple dental extractions.

In a randomized double-blind study, 60 children, aged 4-7 years, undergoing dental extractions of six or more teeth under day-case general anaesthesia, were assigned to receive either tramadol drops 1.5 mg kg-1 (n = 31), or placebo (normal saline) (n = 29), 30 min before surgery. In addition, all received anxiolytic pre-medication of oral midazolam 0.5 mg kg-1 (max 7.5 mg) at the same time. No differences were seen in behaviour, respiratory or cardiovascular assessments. In both groups, 93% were drowsy pre-anaesthetic, 3% were asleep but rousable and less than 4% exhibited minor distress. At induction, mild weeping occurred in 9.7% of the tramadol group and 6.9% of the placebo group (P > 0.05). Active awake recovery took 48.8 min, SD 32.6 in the tramadol group and 36.4 min, SD 29.6 in the placebo group (P > 0.05). Post-operative analgesia (paracetamol 120 mg) was given to 19.4% of the tramadol group compared with 82.8% of the placebo group (P < 0.05), after which the Hannalah objective pain scale scores were comparable. Analysis of the Oucher six faces pain scale showed significantly better analgesia in the tramadol group at all time points, the pain score being half that of the placebo group at 60 min and one third from 60 to 120 min (P < 0.05). No adverse respiratory or cardiovascular effects were seen. For children undergoing multiple extractions, 10.7, SD 3.0, effective postextraction analgesia was provided.

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.

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.

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.

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.

An observer-blind randomised parallel group study comparing the efficacy and tolerability of tenoxicam and piroxicam in the treatment of post-operative pain after oral surgery.

Tenoxicam and piroxicam were compared for analgesic efficacy in 58 patients undergoing removal of bilateral impacted third molar teeth, under general anaesthesia. Pain intensity was assessed over a 7 day period by the patient using verbal and visual analogue scales. The patients received one hour pre-operatively dormicum 7.5 mg orally and either tenoxicam 40 mg or piroxicam 40 mg rectally. This was followed by tenoxicam 20 mg daily in effervescent form, or piroxicam 20 mg daily in despersible tablet form for 7 days. Surgical and anaesthetic techniques were standardized for all patients. Therapeutic gain was assessed by comparing hourly pain levels 4 hours post-operatively and then twice daily for 7 days. Trismus was evaluated pre-operatively, at one hour, 24 hours and 7 days post-operatively. Analysis of the results showed a statistical significant difference between the treatment groups only 4 hours post-operatively, patients in the tenoxicam group experiencing less pain than those in the piroxicam group (p = < 0.05).

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 midazolam alone and midazolam combined with ketamine for sedation of pediatric dental patients.

PURPOSE: The safety and efficacy of a new sedation technique for children having dental procedures under local anesthesia were evaluated. MATERIALS AND METHODS: One hundred children between the ages of 2 and 7 years who required sedation for dental procedures were administered either a combination of midazolam (0.35 mg/kg) and ketamine (5 mg/kg) or midazolam alone (1 mg/kg) rectally 30 minutes before removal to the dental chair. Pulse rate, respiratory rate, arterial pressure, oxygen saturation, adverse reactions, postoperative recovery, and behavior were recorded. RESULTS: Satisfactory sedation and anxiolysis were achieved with both drugs used in the study. When evaluating postoperative recovery, statistically significantly more children receiving midazolam alone were fully awake on admission to the recovery room and 30 minutes later. Results of physiologic monitoring, behavioral ratings, and adverse effects are reported. Excessive salivation occurred in 26% of children receiving the combination of drugs, compared with 14% receiving midazolam alone. Seven (14%) of the children receiving the combination of drugs hallucinated, compared with 21 (42%) receiving midazolam alone. Both drug groups had reliably good anxiolysis and sedation without loss of respiratory drive or protective airway reflexes. CONCLUSION: The use of a combination of midazolam and ketamine or midazolam alone is a safe, effective, and practical approach to managing children for minor dental procedures under local anesthesia. With this technique, advanced airway management proficiency is recommended.

An evaluation of the effect of oral ketamine and standard oral premedication in the sedation of paediatric dental patients.

We compared the effectiveness of ketamine with standard oral premedication (SOP) in 60 children, 2-7 years of age, sedated orally for dental treatment under local anaesthesia. Children were assigned randomly to receive either 12.5 mg/kg ketamine or 0.5 ml/kg of SOP orally 60 min before the dental procedure. Pulse rate, systolic, diastolic and mean arterial pressures, respiratory rates and blood oxygen saturation were recorded prior to drug administration, 60 min thereafter and immediately before the dental procedure. Anxiety levels were measured at the same time intervals. The level of sedation was measured 60 min after drug administration. No significant differences were found in the anxiety levels between the groups 60 min after oral administration. The level of sedation in both groups before surgery was excellent. Operator evaluation for overall effectiveness of treatment showed that sedation was very good in 60 per cent of children in the ketamine group compared with 20 per cent in the SOP group. More children in the ketamine group were better sedated (p < 0.05). Both premedicants produce good sedation and anxiolysis 60 min after premedication and immediately before the surgical procedure.

Randomized double-blind comparison of tiaprofenic acid and diclophenac sodium after third molar surgery.

OBJECTIVE: This study compares the effectiveness of tiaprofenic acid with diclophenac sodium over a 7-day period with respect to pain, facial swelling, and trismus. STUDY DESIGN: Sixty patients who required general anesthesia for removal of bilateral impacted third molar teeth were included. Intraoperatively, they received intramuscular injections of either tiaprofenic acid or diclophenac sodium followed respectively by tiaprofenic acid tablets for 5 days and placebo for an additional 2 days or diclophenac sodium tablets for the full 7 days. Surgical and anesthetic techniques were standardized. Pain levels were compared hourly for 4 hours postoperatively and thereafter twice daily for 7 days. Changes in facial swelling and trismus were compared on days 2 and 7 postoperatively. RESULTS: No statistically significant difference was found between the two treatment groups with respect to pain or facial swelling. Only with respect to recovery in mouth-opening ability (trismus) from day 2 to day 7 did diclophenac sodium reveal a statistically significant advantage (p = 0.0452).

Cardiac dysrhythmias associated with intravenous lorazepam, diazepam, and midazolam during oral surgery.

The incidence and nature of cardiac dysrhythmias occurring during intravenous sedation with lorazepam, diazepam, and midazolam for oral surgery were studied. Sixty American Society of Anesthesiologists (ASA) I patients of both sexes between the ages 17 and 32 years were randomly allocated to three groups. Groups received either intravenous lorazepam (.05 mg/kg), diazepam (.25 mg/kg), or midazolam (.1 mg/kg) prior to the oral surgical procedure. Electrocardiograms were made before medication and thereafter throughout the entire procedure. Of the 60 patients studied, 16 (26.7%) exhibited dysrhythmias during the surgical procedure. If sinus dysrhythmias were excluded as a cause of abnormal rhythms, only six patients (10%) exhibited dysrhythmias during surgery. No atrial or ventricular premature beats were recorded for the lorazepam group. In the diazepam group five of the patients (25%) exhibited dysrhythmias; 15% were mainly unifocal ventricular premature beats. Only one patient in the midazolam group exhibited unifocal ventricular premature beats.

Conscious sedation with midazolam in a dental patient with a spastic nerve/muscle disorder--a case report.

A case is presented in which intravenous midazolam was titrated to sedate a patient with a spastic nerve/muscle disorder during a post and crown preparation procedure. The patient, a 29-year-old woman with uncontrolled limb and body movements, was given midazolam in small incremental doses, not exceeding 0.5mg, at approximate intervals of 10 minutes after receiving a bolus dose of 0.75mg at the start of the procedure. The 0.5mg doses were given every time limb/body movements increased. The total dose of 0.1mg/kg, often given as a bolus for sedation in dentistry, was not exceeded during the procedure. No adverse effects were observed and the patient remained well sedated and cooperative during the entire procedure which was completed to the full satisfaction of all involved.

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.

Serum potassium and sodium levels following intravenous suxamethonium in pediatric dental anesthesia.

The effects of rectally administered midazolam (.35 mg/kg), diazepam (.70 mg/kg), and placebo used as preanesthetic medications on serum levels of potassium after intravenous suxamethonium in children undergoing dental extractions under halothane anesthesia were examined. Ninety patients between the ages of 2 and 7 years were randomly allocated into three groups in this double-blind parallel study. Blood samples were taken immediately after induction with halothane (Pre-S) and at 1, 3, 5, 10, and 15 minutes after administration of suxamethonium (Post-S). Serum from these samples was analyzed in duplicate for potassium and sodium and the data analyzed statistically. The results showed that mean serum potassium levels tended to remain higher in the two groups that had received a benzodiazepine than in the controls at 5, 10, and 15 minutes Post-S. Although the increases in plasma potassium differed significantly from Pre-S at the various times within each patient group, no significant intergroup differences could be shown except at the 15 minute Post-S stage, when the mean serum potassium level of the placebo group was significantly closer to its Pre-S value than that of the diazepam group. At all stages Post-S the mean serum sodium levels for each of the three groups showed statistically significant decreases from their Pre-S values. However, no statistically significant intergroup differences could be shown.