Nebulized Bupivacaine Analgesia for Cleft Palate Repair

NCT04928352 | Recruiting Phase 3 DMC

• 1 other identifier: 17300615
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• the total postoperative consumption of rescue analgesics

  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.

  24 hour after surgery

Secondary Outcomes (2)

• Postoperative FLACC score

  24 hour postoperative

• The time to first request for rescue analgesics

  24 hour postoperative

Study Arms (2)

Group B

EXPERIMENTAL

Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Drug: Bupivacaine Hydrochloride

Group C

PLACEBO COMPARATOR

Same volume of nebulized saline placebo

Other: 0.9% saline

Interventions

Bupivacaine Hydrochloride DRUG

Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Also known as: marcaine

Group B

0.9% saline OTHER

Preoperative nebulized same volume of saline placebo

Also known as: Normal saline

Group C

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

RECRUITING

Related Publications (1)

• Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.

  PMID: 24525630 RESULT

MeSH Terms

Conditions

Cleft Palate

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Omar Soliman, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Omar Soliman, MD

CONTACT

01101266040; omarmakram347@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 14, 2021
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

EG (1)