Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

Phase 4

• Conditions: Tonsillectomy
• Interventions: Drug: Nacl 0,9 %; Drug: Bupivacaine 0.5% , Dexamethasone; Drug: Bupivacaine 0.5%

• Registration Number: NCT03443778
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2017-12-27
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-21
• Last Update Submitted: 2018-02-21
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-03-15
• Study Completion: 2018-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nacl 0,9% (Control) group	Nacl 0,9 %	Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
Bupivacaine 0,5% , Dexamethasone	Bupivacaine 0.5% , Dexamethasone	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
Bupivacaine 0,5%	Bupivacaine 0.5%	Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery

Primary Outcome Measures

Name	Time	Method
Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)	postoperative 7day .	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

Secondary Outcome Measures

Name	Time	Method
Parents satisfaction	postop seven day	Parents satisfaction will measure visual analog scale (VAS) . 0 is the best 10 is the worse score.
Side effects (nause,vomiting)	postop seven day	Nause will measure with visual analog scale (VAS) . 0 is the best 10 is the worse score. vomiting will measure with present/absent
Rescue analgesic consumption at home	postop 2-3-5-6- 7. day	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)
Rescue analgesic consumption at PACU (post-anaesthesia care unit)	At Pacu 1 hour	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).
Rescue analgesic consumption first day at hospital	4,8,12,24 h at hospital in first postoperative day.	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)

Trial Locations

Locations (1)

Leyla Kilinc; 🇹🇷 İstanbul, Sisli, Turkey