A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Cleft Palate Clinical Trial

Official title:

Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Nalbuphine in Children With Cleft Palate Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928391
• Other study ID #: 17300616
• Status: Recruiting
• Phase: Phase 3
• Start date: June 20, 2021
• Est. completion date: May 20, 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Omar Soliman, MD
• Phone: 01101266040
• Email: omarmakram347[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 20, 2025
• Est. primary completion date: May 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Drug:
• Dexmedetomidine
A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery
• Nalbuphine
A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery

Other:
• 0.9% saline
Same volume of saline placebo IV at the end of surgery

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut
Egypt	Omar Soliman	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Milic M, Goranovic T, Knezevic P. Complications of sevoflurane-fentanyl versus midazolam-fentanyl anesthesia in pediatric cleft lip and palate surgery: a randomized comparison study. Int J Oral Maxillofac Surg. 2010 Jan;39(1):5-9. doi: 10.1016/j.ijom.2009 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Pediatric Anesthesia Emergence Delirium (PAED) score	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	1 hour postoperative
Secondary	FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.	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.	1 hour postoperative