Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Minia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post Tonsillectomy Pain

Treatments: Drug: Saline 0.9%; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05109416

59:4/2021

Details and patient eligibility

About

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

Full 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

Enrollment: 210 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve

Treatment:

Drug: Bupivacaine Hydrochloride 0.5% Injection Solution

Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline 0.9%