Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928352
• Other study ID #: 17300615
• Status: Recruiting
• Phase: Phase 3
• Start date: June 14, 2021
• Est. completion date: June 20, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Omar Soliman, MD
• Phone: 01101266040
• Email: omarmakram347[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

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; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 20, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Drug:
• Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
• Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Other:
• 0.9% saline
Preoperative nebulized same volume of saline placebo

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 =3. 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, 2, 3, 4, 5, 6, 12 and 24 hour postoperative.	24 hour after surgery
Secondary	Postoperative FLACC score	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, 2, 3, 4, 5, 6, 12 and 24 hour postoperative.	24 hour postoperative
Secondary	The time to first request for rescue analgesics	Recording the first time when patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were =3.	24 hour postoperative