CompletedPhase 3

A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

Egypt60 participantsStarted 2021-06-20

Plain-language summary

The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.

Who can participate

Age range1 Year – 7 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II * Elective cleft palate repair ± cleft lip surgery under general anesthesia. Exclusion Criteria: * Ventriculo-peritoneal shunt * Suspected meningitis * Congenital hydrocephalus * Clinical signs of suspected increased intracranial pressure * On treatment for seizures or metabolic diseases * Children with developmental delay * Hypersensitivity to dexmedetomidine or nalbuphine

What they're measuring

the Pediatric Anesthesia Emergence Delirium (PAED) score

Timeframe: 1 hour postoperative

Trial details

NCT IDNCT04928391

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-05

View on ClinicalTrials.gov More Cleft Palate trials