Efficacy of intranasal ketamine and midazolam for pediatric sedation: A double-blind, randomized clinical trial

Hossein Khoshrang1, Cyrus Emir Alavi1, Siamak Rimaz1

  • 1Anesthesiology Research Center, Department of Anesthesiology, Alzahra Hospital, Guilan University of Medical Sciences , Rasht, Iran.

Insights

Intranasal ketamine and midazolam effectively sedate pediatric patients before surgery. While both are safe, ketamine prolonged recovery time in children undergoing urologic procedures.

Area of Science:

  • Anesthesiology and Pain Management
  • Pediatric Surgery
  • Pharmacology

Background:

  • Pediatric patients experience significant fear and anxiety during surgical procedures.
  • Optimal drug and administration route for pediatric premedication remain undetermined.
  • Intranasal (IN) administration offers a needle-free alternative for pediatric medication delivery.

Purpose of the Study:

  • To compare the efficacy and safety of intranasal ketamine versus midazolam for premedication in pediatric patients.
  • To evaluate sedation and separation anxiety scores in children receiving IN ketamine or midazolam.
  • To assess hemodynamic stability and postoperative side effects associated with IN premedication.

Main Methods:

  • A study involving 71 eligible pediatric patients aged 2 to 6 years undergoing elective urologic surgeries.
  • Comparison of sedation and separation anxiety scores between intranasal ketamine (Group K) and intranasal midazolam (Group M) groups.
  • Documentation and comparison of hemodynamic parameters and postoperative adverse events.

Main Results:

  • No significant difference in sedation scores (P=0.17) or separation anxiety scores (P=0.01) between ketamine and midazolam groups.
  • Significantly longer recovery time in the ketamine group (38.19±6.67 min) compared to the midazolam group (27.86±4.42 min) (P=0.01).
  • Hemodynamic parameters remained within physiological limits in both groups, with no significant fluctuations.

Conclusions:

  • Both intranasal ketamine and midazolam are effective and safe premedication options for inducing sedation in young children.
  • Intranasal midazolam may offer a faster recovery profile compared to intranasal ketamine in pediatric surgical patients.
  • Further research may explore optimal dosing and specific indications for each agent in pediatric premedication.
Abstract

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