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A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Recruiting
1-7 years
All
Phase 3

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Overview

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

Description

A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or a single dose of 0.1 mg/kg IV nalbuphine (Group N) or same volume of saline placebo (Group C).

Eligibility

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

Study details
    Cleft Palate

NCT04928391

Assiut University

27 May 2024

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