Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

NCT ID: NCT05109416

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-17
• Study Completion Date: 2022-03-22

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

Conditions

Post Tonsillectomy Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride 0.5% Injection Solution

Intervention Type: DRUG

Local anesthetic

Group B

Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches

Group Type: PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type: DRUG

Isotonic crystaloid

Interventions

Bupivacaine Hydrochloride 0.5% Injection Solution

Local anesthetic

Intervention Type: DRUG

Saline 0.9%

Isotonic crystaloid

Intervention Type: DRUG

Other Intervention Names

Marcaine; Saline 0.9 %

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

basem saed abdalla

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medcine

Minya, , Egypt

Countries

Egypt

Other Identifiers

59:4/2021

Identifier Type: -

Identifier Source: org_study_id