Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Study Overview
=================
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

Official Title
-----------------
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Conditions
-----------------
Post Tonsillectomy Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hydrochloride 0.5% Injection Solution
* Drug: Saline 0.9%


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* Local anesthetic<br>* Other names: Marcaine;|
| Placebo Comparator: Group B<br>Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches | Drug: Saline 0.9%<br>* Isotonic crystaloid<br>* Other names: Saline 0.9 %;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glossopharyngeal nerve block