Nebulized Bupivacaine Analgesia for Cleft Palate Repair

April 11, 2023 updated by: Omar Makram Soliman, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, Assuit universi
        • Recruiting
        • Assiut University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group B1
Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Drug: Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Other Names:
  • marcaine
Drug: Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Other Names:
  • marcaine
Experimental: Group B2
Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Drug: Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Other Names:
  • marcaine
Drug: Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Other Names:
  • marcaine
Placebo Comparator: Group C
Same volume of nebulized saline placebo
Other: 0.9% saline
Preoperative nebulized same volume of saline placebo
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ≥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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 2, 3, 4, 5, 6, 12 and 24 hour postoperative.
24 hour postoperative
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 ≥3.
24 hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Omar Soliman, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Anticipated)

June 10, 2024

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cleft Palate

Clinical Trials on Bupivacaine Hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe