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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01582022
Other study ID # E-12-598
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received April 15, 2012
Last updated April 19, 2012

Study information

Verified date April 2012
Source King Saud University
Contact abdulmalik s alsaied, sborl
Phone 00966504808705
Email malik0099@hotmail.com
Is FDA regulated No
Health authority Saudi Arabia: Ministry for Higher Education
Study type Interventional

Clinical Trial 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.


Description:

Evaluation of The Effect of Bupivacaine (marcaine) in Reducing Early Post Tonsillectomy Pain (Prospective, randomized, intra-individual study.) Study guidelines

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all patients undergoing tonsillectomy

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
local application for 5 minutes
normal saline
local application for 5 minutes

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
King Saud University
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