Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Phase 1

Completed

• Conditions: Post Tonsillectomy Pain
• Interventions: Drug: Bupivacaine Hydrochloride 0.5% Injection Solution; Drug: Saline 0.9%

• Registration Number: NCT05109416
• Lead Sponsor: Minia University

Brief Summary

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

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 Timeline

• Study Start: 2021-10-17
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-05
• Primary Completion: 2022-03-05
• Study Completion: 2022-03-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Bupivacaine Hydrochloride 0.5% Injection Solution	Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve
Group B	Saline 0.9%	Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches

Primary Outcome Measures

Name	Time	Method
The first call for analgesia	In 24 hours	Pain assessment using VAS scale

Secondary Outcome Measures

Name	Time	Method
The analgesic consumption	In 24 hours	The total analgesic consumption for pain rest and swallowing

Trial Locations

Locations (1)

Faculty of Medcine; 🇪🇬 Minya, Egypt