a comparative evaluation of intranasal dexmedetomidine vs midazolam for preoperative sedation in children

Phase 4

Active, not recruiting

• Conditions: All children belonging to ASA 1 health status

• Registration Number: CTRI/2018/04/013123
• Lead Sponsor: R G Kar Medical College Hospital Kolkata

Brief Summary

**OBJECTIVES:**The study aimed at comparing the efficacies of intranasal dexmedetomidine &intranasal midazolam regarding producing sedation at induction. The secondaryend- points were preoperative heart rate & systolic bloos pressure changesafter administration of either drugs. We also looked at sedation &analgesia status at the time of induction, recovery as well as 3 hours & 6hours post operatively.

**METHODS:**Study subjects comprised of children aged 2-8 years posted for elective surgeryunder general anesthesia. It was a double blind randomized control trialcomprising of 90 subjects divided into 2 groups. group A (n=42) received 0.2μg/kg dexmedetomidine & group B (n=48) 0.5 mg/kg midazolam by intranasalroute 45 minutes prior to induction. sedation & analgesia scores wereassessed by Ramsay Sedation Scale & Observer Pain Scale respectively. heartrate & systolic blood pressures were recorded every 15 minutes pre-operatively after administration of drugs. sedation & analgesia scores wererecorded at induction, recovery, after 3 hours & 6 hours post operatively.

**RESULTS:**93% subjects in group A & 60% in group B achieved satisfactory sedation atthe time of induction. Sedation status & analgesia obtained at the time ofinduction, recovery, 3 hours & 6 hours post operatively were significantlybetter in group A. Pre- operative changes in HR & SBP in both groups werecomparable.

**CONCLUSION:**Intranasal dexmedetomidine is safe &more effectivethan intranasal midazolam for pre operative sedation in children. Also,intranasal dexmedetomidine is a superior agent than intranasal midazolam forpost operative analgesia in pediatric population.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-26
• Last Update Posted: 2017-02-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Children aged 2-8 yrs belonging to ASA physical status I or II scheduled for elective surgery.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
satisfactory sedation score achieved at the time of induction	45 mins after administration of drug

Trial Locations

Locations (1)

R G Kar Medical College & Hospital, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

R G Kar Medical College & Hospital, Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Arcojit Ghosh

Principal investigator

9830245087

arcojitg@gmail.com