Clinical trial NCT03443778: Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.
Official title: Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tonsillectomy
Keywords: tonsillectomy pain
dexamethasone
bupivacaine
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)
timeFrame: postoperative 7day .
Secondary outcomes:
measure: Side effects (nause,vomiting)
timeFrame: postop seven day
measure: Rescue analgesic consumption at PACU (post-anaesthesia care unit)
timeFrame: At Pacu 1 hour
measure: Rescue analgesic consumption first day at hospital
timeFrame: 4,8,12,24 h at hospital in first postoperative day.
measure: Rescue analgesic consumption at home
timeFrame: postop 2-3-5-6- 7. day
measure: Parents satisfaction
timeFrame: postop seven day
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Leyla Kilinc
state: Sisli
Study officials:
affiliation: Md
name: Leyla Kilinc, Md
role: STUDY_DIRECTOR
References:
citation: Bayram A, Dogan M, Cihan C, Karatas D, Gokahmetoglu G, Ozcan I. The Efficacy of Levobupivacaine Hydrochloride-Dexamethasone Infiltration for Post-Tonsillectomy Pain in Adults. J Craniofac Surg. 2015 Oct;26(7):e651-3. doi: 10.1097/SCS.0000000000001975.
citation: Basuni AS, Ezz HA, Albirmawy OA. Preoperative peritonsillar infiltration of dexamethasone and levobupivacaine reduces pediatric post-tonsillectomy pain: a double-blind prospective randomized clinical trial. J Anesth. 2013 Dec;27(6):844-9. doi: 10.1007/s00540-013-1638-0. Epub 2013 May 25.