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Completed

NCT Number: NCT04928391

A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

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.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Omar Soliman, Asyut, Assuit, Egypt

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

0.9% saline

Other

Same volume of saline placebo IV at the end of surgery

Other names: Normal saline

Primary outcomes

  1. the Pediatric Anesthesia Emergence Delirium (PAED) score

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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