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

J Oral Maxillofac Surg. 1996 Jul;54(7):838-44; discussion 845-6. doi: 10.1016/s0278-2391(96)90531-5.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Rectal
  • Anesthesia Recovery Period
  • Anesthesia, Dental
  • Anesthesia, Local
  • Child
  • Child, Preschool
  • Conscious Sedation / methods*
  • Conscious Sedation / statistics & numerical data
  • Dental Anxiety / physiopathology
  • Dental Anxiety / therapy*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Ketamine* / administration & dosage
  • Ketamine* / adverse effects
  • Midazolam* / administration & dosage
  • Midazolam* / adverse effects
  • Tooth Extraction / psychology


  • Ketamine
  • Midazolam