Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-04-15

Brief Summary

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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% .

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Detailed Description

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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.

Conditions

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Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nacl 0,9% (Control) group

Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery

Group Type ACTIVE_COMPARATOR

Nacl 0,9 %

Intervention Type DRUG

Injectable Solution

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5%

Intervention Type DRUG

Marcaine 0.5% Injectable Solution

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5% , Dexamethasone

Intervention Type DRUG

Bupivacaine 0.5% , Dexamethasone

Interventions

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Bupivacaine 0.5%

Marcaine 0.5% Injectable Solution

Intervention Type DRUG

Bupivacaine 0.5% , Dexamethasone

Intervention Type DRUG

Nacl 0,9 %

Injectable Solution

Intervention Type DRUG

Other Intervention Names

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Marcaine 0,5% Dekort Marcaine 0,5 % Injectable Solution Serum Physiologic

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No