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An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

Primary Purpose

Impacted Third Molar Tooth, PAIN

Status
Suspended
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
diclofenac / acetaminophen /codeine
ibuprofen/acetaminophen/codeine
Sponsored by
University of Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients older than 18 years of age
  • patients undergoing third molar extractions
  • patients with or willing to get orthopantomogram for assessment of impacted third molars

Exclusion Criteria:

  • patients younger than 18 years
  • patients not willing to consent to the study
  • patients with associated co-morbidities
  • patients not willing to undergo radiological evaluation
  • patients allergic to medications used in the study
  • pregnant patients

Sites / Locations

  • Dr Silas bere

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diclofenac /Acetaminophen/Codeine

Ibuprofen/Acetaminophen/codeine

Arm Description

routine pain medication used in post extraction pain management

routine pain medication used in post extraction pain management

Outcomes

Primary Outcome Measures

post operative pain
record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.

Secondary Outcome Measures

Time rescue medication is used
rescue medication
cheek swelling
amount of cheek swelling post extraction

Full Information

First Posted
April 28, 2021
Last Updated
January 4, 2023
Sponsor
University of Zimbabwe
Collaborators
UZ-CHS-PERFECT
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1. Study Identification

Unique Protocol Identification Number
NCT04874675
Brief Title
An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery
Official Title
A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Covid 19 lockdown
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zimbabwe
Collaborators
UZ-CHS-PERFECT

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .
Detailed Description
Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth, PAIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac /Acetaminophen/Codeine
Arm Type
Active Comparator
Arm Description
routine pain medication used in post extraction pain management
Arm Title
Ibuprofen/Acetaminophen/codeine
Arm Type
Active Comparator
Arm Description
routine pain medication used in post extraction pain management
Intervention Type
Drug
Intervention Name(s)
diclofenac / acetaminophen /codeine
Other Intervention Name(s)
diclofenac/paracetamol/codeine phosphate
Intervention Description
routine pain medication used post extraction of third molars
Intervention Type
Drug
Intervention Name(s)
ibuprofen/acetaminophen/codeine
Other Intervention Name(s)
ibuprofen/paracetamol/codeine phosphate
Intervention Description
routine pain medication used post extraction of third molars
Primary Outcome Measure Information:
Title
post operative pain
Description
record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.
Time Frame
within 7 days post extraction
Secondary Outcome Measure Information:
Title
Time rescue medication is used
Description
rescue medication
Time Frame
within 7 days post extraction
Title
cheek swelling
Description
amount of cheek swelling post extraction
Time Frame
with in 7 days post extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients older than 18 years of age patients undergoing third molar extractions patients with or willing to get orthopantomogram for assessment of impacted third molars Exclusion Criteria: patients younger than 18 years patients not willing to consent to the study patients with associated co-morbidities patients not willing to undergo radiological evaluation patients allergic to medications used in the study pregnant patients
Facility Information:
Facility Name
Dr Silas bere
City
Harare
ZIP/Postal Code
00263
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

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