A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

Phase 3RecruitingNCT04928391

Assiut University60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cleft Palate

Interventions

DexmedetomidineDRUG

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

0.9% salineOTHER

Same volume of saline placebo IV at the end of surgery

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (2)

Omar Soliman

Asyut, Assuit, Egypt

RECRUITING

Assiut university hospital

Asyut, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 hour postoperative

Secondary Outcomes

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.

Time frame: 1 hour postoperative

Central Contacts

Omar Soliman, MD

CONTACT

01101266040 omarmakram347@yahoo.com

Data from ClinicalTrials.gov

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