Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

April 21, 2022 updated by: basem saed abdalla, Minia University
Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .

The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .

This is prospective , double blinded , randomized study

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Faculty of Medcine

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

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • average weight is 10_50 kg
  • patient is generally stable
  • indication of tonsillectomy is recurrent tonsillitis
  • Ability to self report pain

Exclusion Criteria:

  • Hypersensitivity to bupivacaine
  • Obstructive sleep apnea syndrome
  • Pulmonary or cardic diseases

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
Active Comparator: Group A
Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve
Drug: Bupivacaine Hydrochloride 0.5% Injection Solution
Local anesthetic
Other Names:
  • Marcaine
Placebo Comparator: Group B
Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches
Drug: Saline 0.9%
Isotonic crystaloid
Other Names:
  • Saline 0.9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The first call for analgesia
Time Frame: In 24 hours
Pain assessment using VAS scale
In 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analgesic consumption
Time Frame: In 24 hours
The total analgesic consumption for pain rest and swallowing
In 24 hours

Collaborators and Investigators

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

Sponsor

Minia University

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)

October 17, 2021

Primary Completion (Actual)

March 5, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59:4/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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