Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

NCT03443778 | Unknown Phase 4

• 1 other identifier: 907-12.12.2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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% .

Conditions

Tonsillectomy

Keywords

tonsillectomy pain; dexamethasone; bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Side effects (nause,vomiting)

  postop seven day

• Rescue analgesic consumption at PACU (post-anaesthesia care unit)

  At Pacu 1 hour

• Rescue analgesic consumption first day at hospital

  4,8,12,24 h at hospital in first postoperative day.

• Rescue analgesic consumption at home

  postop 2-3-5-6- 7. day

• Parents satisfaction

  postop seven day

Study Arms (3)

Nacl 0,9% (Control) group

ACTIVE COMPARATOR

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

Drug: Nacl 0,9 %

Bupivacaine 0,5%

ACTIVE COMPARATOR

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%

Bupivacaine 0,5% , Dexamethasone

ACTIVE COMPARATOR

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

Interventions

Bupivacaine 0.5% DRUG

Marcaine 0.5% Injectable Solution

Also known as: Marcaine 0,5%

Bupivacaine 0,5%

Bupivacaine 0.5% , Dexamethasone DRUG

Bupivacaine 0.5% , Dexamethasone

Also known as: Dekort, Marcaine 0,5 % Injectable Solution

Bupivacaine 0,5% , Dexamethasone

Nacl 0,9 % DRUG

Injectable Solution

Also known as: Serum Physiologic

Nacl 0,9% (Control) group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing
• Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine hypersensitivity Dexamethasone hypersensitivity Taking chronic systemic steroids

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Leyla Kilinc

Istanbul, Sisli, 34360, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26468853 BACKGROUND

• 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.

  PMID: 23708881 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Leyla Kilinc, Md

  Md

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: February 23, 2018
• Study Start: December 15, 2017
• Primary Completion: March 15, 2018
• Study Completion: April 15, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)