A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study

J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.

Abstract

Objectives: To evaluate and compare the efficacy and safety of Intranasal (IN) Dexmedetomidine, Midazolam and Ketamine in producing moderate sedation among uncooperative pediatric dental patients.

Study design: This randomized triple blind comparative study comprises of eighty four ASA grade I children of both sexes aged 4-14 years, who were uncooperative and could not be managed by conventional behavior management techniques. All the children were randomized to receive one of the four drug groups Dexmedetomidine 1 microg/ kg (D1), 1.5 microg/kg (D2), Midazolam 0.2 mg/kg (M1) and Ketamine 5 mg/kg (K1) through IN route. These drug groups were assessed for efficacy and safety by gauging overall success rate and by monitoring vital signs, respectively.

Results: The onset of sedation was significantly rapid with M1 and K1 as compared to D1 and D2 (p = < 0.001). The overall success rate was highest in D2 (85.7%) followed by D1 (81%), K1 (66.7%) and M1 (61.9%), however, the difference among them was not statistically significant (p = > 0.05). Even though all the vital signs were within physiological limits, there was significant reduction in pulse rate (PR) (p = < 0.001) and systolic blood pressure (SBP) (p = < 0.05) among D1 and D2 as compared to M1 and K1. D1, D2 and K1 produced greater intra- and post-operative analgesia as compared to M1. There were no significant adverse effects with any group.

Conclusion: Dexmedetomidine, Midazolam and Ketamine, all the three drugs evaluated in the present study can be used safely and effectively through IN route in uncooperative pediatric dental patients for producing moderate sedation.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Adolescent
  • Analgesics / administration & dosage*
  • Anesthesia Recovery Period
  • Anesthesia, Dental / methods*
  • Blood Pressure / drug effects
  • Child
  • Child Behavior / drug effects
  • Child, Preschool
  • Conscious Sedation / methods*
  • Dental Anxiety / prevention & control
  • Dexmedetomidine / administration & dosage*
  • Female
  • Heart Rate / drug effects
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Ketamine / administration & dosage*
  • Male
  • Midazolam / administration & dosage*
  • Monitoring, Physiologic
  • Oxygen / blood
  • Pain, Postoperative / prevention & control
  • Patient Compliance
  • Patient Safety
  • Respiration / drug effects
  • Treatment Outcome

Substances

  • Analgesics
  • Hypnotics and Sedatives
  • Dexmedetomidine
  • Ketamine
  • Midazolam
  • Oxygen