Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03443778
• Other study ID #: 907-12.12.2017
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 27, 2017
• Last updated: February 21, 2018
• Start date: December 15, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: February 2018
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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% .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Drug:
• Bupivacaine 0.5%
Marcaine 0.5% Injectable Solution
• Bupivacaine 0.5% , Dexamethasone
Bupivacaine 0.5% , Dexamethasone
• Nacl 0,9 %
Injectable Solution

Locations

Country	Name	City	State
Turkey	Leyla Kilinc	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Bayram A, Dogan M, Cihan C, Karatas D, Gökahmetoglu G, Özcan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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) . If the pain score is still 4 and up it will treated with tramadol 1 mg/kg).	At Pacu 1 hour
Secondary	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.
Secondary	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
Secondary	Parents satisfaction	Parents satisfaction will measure visual analog scale (VAS) . 0 is the best 10 is the worse score.	postop seven day