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NCT Number: NCT04928352

Nebulized Bupivacaine Analgesia for Cleft Palate Repair

In this study we introduce a potent local anesthetic; bupivacaine 0.5% in 0.5 mg/kg dose by nebulization as a preemptive analgesia to compare efficacy and safety in children with 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

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location status: Recruiting

Location contact

Omar Soliman

CONTACT

[email protected]

01101266040

About this study

A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive; Nebulized plain Bupivacaine 0.50% 0.50 mg.kg-1 (Group B) 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

  • Coronary artery disease
  • Hypertension
  • Developmental delay
  • Allergy to study drug

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Other names: marcaine

0.9% saline

Other

Preoperative nebulized same volume of saline placebo

Other names: Normal saline

Primary outcomes

  1. the total postoperative consumption of rescue analgesics

    Time frame: 24 hour after surgery

    Patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4. The FLACC (Face, Legs, Activity, Cry, Consolability). We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 3, 6, 12 and 24 hour postoperative.

Secondary outcomes

  1. Postoperative FLACC score

    Time frame: 24 hour postoperative

    The FLACC (Face, Legs, Activity, Cry, Consolability) is a behavioural pain assessment scale for use in non-verbal or pre-verbal patients unable to self-report their level of pain.We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 3, 6, 12 and 24 hour postoperative.

  2. The time to first request for rescue analgesics

    Time frame: 24 hour postoperative

    Recording the first time when patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4.

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Soliman, MD

CONTACT

[email protected]

01101266040

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2021
Registry last updated
Jan 2, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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