A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04928391

Enrollment

Registered

2021-06-16

Start date

2021-06-20

Completion date

2026-03-20

Last updated

2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

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.

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 same volume of saline placebo (Group C).

Interventions

DRUGDexmedetomidine

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

OTHER0.9% saline

Same volume of saline placebo IV at the end of surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

1 Years to 7 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

STUDY_DIRECTOROmar Soliman

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026