A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04928391

Collaborator

(none)

Enrollment

Locations

Arms

29.7

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Palate	Drug: Dexmedetomidine Drug: Nalbuphine Other: 0.9% saline	Phase 3

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

or same volume of saline placebo (Group C).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 20, 2021

Anticipated Primary Completion Date :

Oct 5, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group D Dexmedetomidine IV at the end of surgery	Drug: Dexmedetomidine A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery Other Names: Precedex
Experimental: Group N Nalbuphine IV at the end of surgery	Drug: Nalbuphine A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery Other Names: nalufin
Placebo Comparator: Group C Same volume of saline placebo IV at the end of surgery	Other: 0.9% saline Same volume of saline placebo IV at the end of surgery Other Names: Normal saline

Arm

Intervention/Treatment

Experimental: Group D

Dexmedetomidine IV at the end of surgery

Drug: Dexmedetomidine

A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery

Other Names:

Precedex

Experimental: Group N

Nalbuphine IV at the end of surgery

Drug: Nalbuphine

A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery

Other Names:

nalufin

Placebo Comparator: Group C

Same volume of saline placebo IV at the end of surgery

Other: 0.9% saline

Same volume of saline placebo IV at the end of surgery

Other Names:

Normal saline

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omar Soliman	Assiut	Assuit	Egypt	Assuit universi
2	Assiut university hospital	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Omar Soliman, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omar Makram Soliman, Lecturer of anesthesia and ICU, Assiut University

ClinicalTrials.gov Identifier:

NCT04928391

Other Study ID Numbers:

17300616

First Posted:

Jun 16, 2021

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cleft Palate

Dexmedetomidine

Nalbuphine

Study Results

No Results Posted as of Mar 29, 2022