Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

Study Overview
=================
Brief Summary
-----------------
Investigators compared in this study peritonsillar infiltration of bupivacaine %0.5 (n=40 participants) versus bupivacaine % 0.5 and dexamethasone (number 40participants ) before surgery for reduce posttonsillectomy pain.And control group (n= 40participants) participants received peritonsillar Nacl 0,9% .

Detailed Description
-----------------
Bupivacaine hydrochloride amid structure,long acting local anesthetic. Dexamethasone has strong anti-inflammatory drug reduce postoperative pain and nause and vomiting.Preoperative iv dexamethasone is routinely using for reduce tonsillectomy pain.Lots of studies show that adding dexamethasone to local anesthetic at peripheral nerve block prolongs the analgesic effect.Also preoperative iv dexamethasone prolongs the analgesic effects of local anesthetic infiltration . Post tonsillectomy pain still a serious problem ,it effects postoperative morbidity.Different medicine combination used to applies for peritonsillar infiltration and multimodal iv and oral medication to reduce posttonsillectomy pain.İn this study investigators will use iv dexamethasone for all participants and investigators hypothesis that adding dexamethasone to bupivacaine for peritonsillar infiltration will reduce postoperative pain scores , consumption of rescue analgesic ,patient and family satisfaction.

Official Title
-----------------
Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.

Conditions
-----------------
Tonsillectomy

Intervention / Treatment
-----------------
* Drug: Bupivacaine 0.5%
* Drug: Bupivacaine 0.5% , Dexamethasone
* Drug: Nacl 0,9 %


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing ExclusionCriteria: Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine hypersensitivity Dexamethasone hypersensitivity Taking chronic systemic steroids

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nacl 0,9% (Control) group<br>Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery | Drug: Nacl 0,9 %<br>* Injectable Solution<br>* Other names: Serum Physiologic;|
| Active Comparator: Bupivacaine 0,5%<br>Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery | Drug: Bupivacaine 0.5%<br>* Marcaine 0.5% Injectable Solution<br>* Other names: Marcaine 0,5%;|
| Active Comparator: Bupivacaine 0,5% , Dexamethasone<br>Bupivacaine 0,5% 1 mg/kg,dexamethasone 0.5 mg/kg (max dosage 8mg) 3-5 ml separately two part for each tonsil before surgery | Drug: Bupivacaine 0.5% , Dexamethasone<br>* Bupivacaine 0.5% , Dexamethasone<br>* Other names: Marcaine 0,5 % Injectable Solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores) | Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed & comfortable 1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated .Pain score will measure at home ; Face Pain Scale 0 no pain 10 worse pain. Every day in the morning after phone call pain scores will ask patient/patient guardians. 4 and up scores will treated | postoperative 7day . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects (nause,vomiting) | Nause will measure with visual analog scale (VAS) . 0 is the best 10 is the worse score. vomiting will measure with present/absent | postop seven day | 
| Rescue analgesic consumption at PACU (post-anaesthesia care unit) | Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed & comfortable 1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated with iv paracetamol (10 mg/kg maximum Daily dosage) . İf the pain score is still 4 and up it will treated with tramadol 1 mg/kg). | At Pacu 1 hour | 
| Rescue analgesic consumption first day at hospital | Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed & comfortable 1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will treated with oral paracetamol (10 mg/kg) | 4,8,12,24 h at hospital in first postoperative day. | 
| Rescue analgesic consumption at home | Pain Scores will measure ; Face Pain Scale 0 no pain 10 worse pain. 4 and up scores will treated with oral paracetamol (10 mg/kg) | postop 2-3-5-6- 7. day | 
| Parents satisfaction | Parents satisfaction will measure visual analog scale (VAS) . 0 is the best 10 is the worse score. | postop seven day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tonsillectomy pain, dexamethasone, bupivacaine