NCT04928391

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 normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
11mo left

Started Jun 2021

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2021Mar 2027

First Submitted

Initial submission to the registry

June 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

June 20, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5.6 years

First QC Date

June 10, 2021

Last Update Submit

December 27, 2025

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.

    1 hour postoperative

Study Arms (2)

Group D

EXPERIMENTAL

Dexmedetomidine IV at the end of surgery

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

Same volume of saline placebo IV at the end of surgery

Other: 0.9% saline

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
Group D
0.9% salineOTHER

Same volume of saline placebo IV at the end of surgery

Also known as: Normal saline
Group C

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Omar Soliman

Asyut, Assuit, Assuit universi, Egypt

RECRUITING

Assiut university hospital

Asyut, Egypt

RECRUITING

Related 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.2009.09.007. Epub 2009 Oct 24.

    PMID: 19854614RESULT

MeSH Terms

Conditions

Cleft Palate

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Omar Soliman

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Omar Soliman, MD

CONTACT

01101266040omarmakram347@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 16, 2021

Study Start

June 20, 2021

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

March 20, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

EG(2)