Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

Sisli Hamidiye Etfal Training and Research Hospital

Status and phase: Unknown; Phase 4

Conditions: Tonsillectomy

Treatments: Drug: Bupivacaine 0.5% , Dexamethasone; Drug: Nacl 0,9 %; Drug: Bupivacaine 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03443778

907-12.12.2017

Details and patient eligibility

About

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% .

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Nacl 0,9% (Control) group

Active Comparator group

Description:

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

Treatment:

Drug: Nacl 0,9 %

Bupivacaine 0,5%

Active Comparator group

Description:

Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery

Treatment:

Drug: Bupivacaine 0.5%

Bupivacaine 0,5% , Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine 0.5% , Dexamethasone