A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- satisfactory sedation score achieved at the time of induction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 2-8 yrs belonging to ASA physical status I or II scheduled for elective surgery.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
satisfactory sedation score achieved at the time of induction
Time Frame: 45 mins after administration of drug
Secondary Outcomes
No secondary outcomes reported
