Evaluation of The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain
NCT ID: NCT01582022
Last Updated: 2012-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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Aim of the study
\- to evaluate the effectiveness of applying bupivacaine intra-operative in reducing early post-tonsillectomy pain
Patients and methods
* It will be a randomized, placebo-controlled, single-blinded study
* one tonsillar fossa will be the tested side, and the other fossa will be the control
* to insure the random selection, the tested and control sides will be selected based on unpredicted method e.g. based on the last number in pt MRN: If the last # is even (0, 2, 4, 6, 8) = right side will be the tested If the last # is odd (1, 3, 5, 7, 9) = left side will be the tested
* Exclusion criteria included :
1. pt with past history of unilateral peritonsillar abscess
2. the current, regular use of a systemic steroid or NSAID
3. a known hypersensitivity to bupivacaine
4. a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
5. pt with poor dental hygiene
* accompanied adenoidectomy is not an exclusion criteria
* the tested side will be : packed (after classic tonsillectomy) with gauze soaked in 0.5% bupivacaine, (2ml of bupivacaine + 2ml NS)for 5 min.
* the control side will undergoing the same of tested side but with normal saline
* post-operative analgesia will be paracetamol
* pain evaluation will be by visual analog scale (fig. 1) and it will be in frequency of 2, 4, 6, 8, 12, 24 hours post-op (frequency can be re-adjusted)
* Data of pain will be collected by the nurse. And they will not know which side is the tested. (single- blind)
* after phase I (data collection). Data will be calculated for P-value and other statistics scores
* Targeted sample size is 35 patients.
* patients will be consented for the possible adverse reactions of local application of the tested medicine (e.g. allergic reactions, Paresthesia). However, because in our study we will not add adrenaline, so differences in incidence of post-tonsillectomy bleeding is not expected.
* data will be statistically analyzed by McNemar's test
* For the data safety monitoring of the study, an independent external otolaryngology consultant (Dr.Ahmed Alarfij) will be assigned to monitor the safety of study participants.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
SINGLE
Study Groups
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local anesthetic
local anesthetic agent
Bupivacaine
local application for 5 minutes
normal saline
comparator
normal saline
local application for 5 minutes
Interventions
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Bupivacaine
local application for 5 minutes
normal saline
local application for 5 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. the current, regular use of a systemic steroid or NSAID
3. a known hypersensitivity to bupivacaine
4. a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
5. pt with poor dental hygiene
ALL
No
Sponsors
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King Saud University
OTHER
Responsible Party
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Abdulmalik S. Alsaied
otolaryngology specialist
Central Contacts
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Other Identifiers
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E-12-598
Identifier Type: -
Identifier Source: org_study_id
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