Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

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

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% .

Study Overview

• Status: Unknown
• Conditions: Tonsillectomy
• Intervention / Treatment: Drug: Nacl 0,9 %; Drug: Bupivacaine 0.5%; Drug: Bupivacaine 0.5% , Dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • İstanbul, Sisli, Turkey, 34360
      • Leyla Kilinc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nacl 0,9% (Control) group; Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery	Drug: Nacl 0,9 %; Injectable Solution; Other Names: Serum Physiologic
ACTIVE_COMPARATOR: 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	Drug: Bupivacaine 0.5%; Marcaine 0.5% Injectable Solution; Other Names: Marcaine 0,5%
ACTIVE_COMPARATOR: 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	Drug: Bupivacaine 0.5% , Dexamethasone; Bupivacaine 0.5% , Dexamethasone; Other Names: Dekort; Marcaine 0,5 % Injectable Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Leyla Kilinc, Md, MD

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2017
• Primary Completion (ANTICIPATED): March 15, 2018
• Study Completion (ANTICIPATED): April 15, 2018

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: dexamethasone; bupivacaine; tonsillectomy pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 907-12.12.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant (IPD) to the other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No