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A study to compare dexmedetomidine with clonidine in decreasing agitation in children following palatoplasty.

A randomized controlled trial comparing dexmedetomidine with clonidine in reducing emergence agitation in children following palatoplasty.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036261
Enrollment
120
Registered
2021-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dexmedetomidine: In this group the participants will receive dexmedetomidine 0.5mcg/kg diluted to 20 ml NS over 10 minutes 15 minutes prior to extubation. Control Intervention1: Clonidi

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1 patients between the age of 6 months and 6 years coming for palatoplasty surgery whose parents are willing to give consent will be enrolled.

Exclusion criteria

Exclusion criteria: Parentâ??s refusal to consent, ASA 2 or above, upper respiratory tract infection, cardiac abnormality, major other systemic illness, coagulopathy, known allergy to alpha agonist agents will be excluded

Design outcomes

Primary

MeasureTime frame
Comparing incidence of emergence agitation of dexmedetomidine with clonidineTimepoint: Emergence agitation will be assessed with FLACC score and Pediatric Anesthesia Emergence Delirium Scale every 5 min from the time of shifting to PACU until discharged

Secondary

MeasureTime frame
Assessment of FLACC score, PAED scale, time to discharge in PACU, amount of rescue analgesics needed in PACUTimepoint: Emergence agitation will be assessed with FLACC score and Pediatric Anesthesia Emergence Delirium Scale every 5 min from the time of shifting to PACU until discharged

Countries

India

Contacts

Public ContactGraceline Vandana Nickelson

Christian Medical College, Vellore.

sajanpg@cmcvellore.ac.in04162282680

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026