A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Phase 3

Recruiting

• Conditions: Cleft Palate
• Interventions: Other: 0.9% saline; Drug: Dexmedetomidine; Drug: Nalbuphine

• Registration Number: NCT04928391
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-16
• Study Start: 2021-06-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-05-05
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	0.9% saline	Same volume of saline placebo IV at the end of surgery
Group D	Dexmedetomidine	Dexmedetomidine IV at the end of surgery
Group N	Nalbuphine	Nalbuphine IV at the end of surgery

Primary Outcome Measures

Name	Time	Method
the Pediatric Anesthesia Emergence Delirium (PAED) score	1 hour postoperative	Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED

Secondary Outcome Measures

Name	Time	Method
FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.	1 hour postoperative	The FLACC is a behavioural pain assessment scale for use for non-verbal or pre-verbal patients unable to self-report their level of pain. Rate your child in each of the five measurement categories, add together, and document total pain score (0 - 10), score 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.

Trial Locations

Locations (2)

Omar Soliman; 🇪🇬 Assiut, Assuit, Egypt

Assiut university hospital; 🇪🇬 Assiut, Egypt