• J. Oral Maxillofac. Surg. · Jul 1996

    Randomized Controlled Trial Comparative Study Clinical Trial

    A double-blind randomized comparison of midazolam alone and midazolam combined with ketamine for sedation of pediatric dental patients.

    • J A Roelofse, J J Joubert, and P G Roelofse.
    • University of Stellenbosch, Tygerberg, South Africa.
    • J. Oral Maxillofac. Surg. 1996 Jul 1;54(7):838-44; discussion 845-6.

    PurposeThe safety and efficacy of a new sedation technique for children having dental procedures under local anesthesia were evaluated.Materials And MethodsOne 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.ResultsSatisfactory 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.ConclusionThe 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.

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