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Clinical Trials/CTRI/2018/04/013123
CTRI/2018/04/013123Active, not recruitingPhase 4

A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial

R G Kar Medical College Hospital Kolkata1 site in 1 country90 target enrollmentStarted: April 26, 2013Last updated:

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

Investigators

Sponsor
R G Kar Medical College Hospital Kolkata
Sponsor Class
Government medical college

Study Sites (1)

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