Evaluation of The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain

NCT01582022 | Unknown Phase 4 DMC

• 1 other identifier: E-12-598
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research Methodology: It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual study in which one tonsillar fossa will be the tested side, and the other fossa will be the control. And the tested side will be packed with bupivacaine for five minutes. In the other hand, the controlled side will be packed for five minutes with gauze soaked in normal saline. The selection of the tested side and controlled side will be randomized based on the last digit in the medical record number (i.e. if the last digit is even then the tested side is the right and if the last digit is odd then the tested side is the left). Pain evaluation will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours post-op.

Conditions

Tonsillectomy

Study Arms (2)

local anesthetic

EXPERIMENTAL

local anesthetic agent

Drug: Bupivacaine

normal saline

PLACEBO COMPARATOR

comparator

Drug: normal saline

Interventions

Bupivacaine DRUG

local application for 5 minutes

Also known as: marcaine

local anesthetic

normal saline DRUG

local application for 5 minutes

Also known as: comparator

normal saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing tonsillectomy

You may not qualify if:

• pt with past history of unilateral peritonsillar abscess
• the current, regular use of a systemic steroid or NSAID
• a known hypersensitivity to bupivacaine
• a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
• pt with poor dental hygiene

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Interventions

Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

abdulmalik s alsaied, sborl

CONTACT

00966504808705; malik0099@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: otolaryngology specialist

Study Record Dates

• First Submitted: April 15, 2012
• First Posted: April 20, 2012
• Last Updated: April 20, 2012

Record last verified: 2012-04