ClinicalTrials.gg
SuspendedNCT04874675Updated Jan 5, 2023

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

An interventional study of diclofenac / acetaminophen /codeine and ibuprofen/acetaminophen/codeine in Impacted Third Molar Tooth and PAIN, sponsored by University of Zimbabwe. Suspended at 1 site in Zimbabwe. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by University of Zimbabwe · Not applicable, Interventional, and Treatment

Why this study was suspended
Covid 19 lockdown
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies testing diclofenac in Pain — 1 open to participants now, 1 under way, none of them phase 3. Diclofenac · Pain.

Enrollment
20th of 37
78 · median 80
Started
2023
the only one that year
No phase
8 of 37
none open now
Registered
32nd of 37
by date

Among the 37 studies testing diclofenac in Pain, this one is the 20th largest by enrollment, is the only one that started in 2023, is one of 8 with no phase, and was the 32nd registered.

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

Browse Pain studies →

Open to participants now

1 of the 37 studies testing diclofenac in Pain is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

About diclofenac

Diclofenac: first FDA approval 1988 (VOLTAREN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies testing diclofenac in Pain, or all of them as a file.
02

Study 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 .

Read the 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.

03

Conditions studied

  • Impacted Third Molar Tooth
  • PAIN

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Active comparator
    Diclofenac /Acetaminophen/Codeine

    routine pain medication used in post extraction pain management

    Drug: diclofenac / acetaminophen /codeine

  • Active comparator
    Ibuprofen/Acetaminophen/codeine

    routine pain medication used in post extraction pain management

    Drug: ibuprofen/acetaminophen/codeine

Interventions

  • Drugdiclofenac / acetaminophen /codeine

    Drug pages: Diclofenac · Acetaminophen · Codeine

    routine pain medication used post extraction of third molars

    Also known as: diclofenac/paracetamol/codeine phosphate

  • Drugibuprofen/acetaminophen/codeine

    Drug pages: Ibuprofen · Acetaminophen · Codeine

    routine pain medication used post extraction of third molars

    Also known as: ibuprofen/paracetamol/codeine phosphate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 7 days post extraction

Secondary outcomes

  1. Time rescue medication is used

    rescue medication

    Time frame: within 7 days post extraction

  2. cheek swelling

    amount of cheek swelling post extraction

    Time frame: with in 7 days post extraction

07

Study locations

1 site
  • Dr Silas bere
    Harare, 00263, Zimbabwe
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2023; primary completion for Dec 2023, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2021
First posted
May 6, 2021
StartEst.
Mar 2023
Primary completionEst.
Dec 2023
CompletionEst.
Apr 2024
Last update
Jan 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04874675
Lead sponsor
University of Zimbabwe
Collaborators
UZ-CHS-PERFECT
Responsible party
Silas Bere (Lecturer, University of Zimbabwe) — Principal investigator
First posted
May 6, 2021
Start date
Mar 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jan 5, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Diclofenac · Acetaminophen · Codeine · Ibuprofen

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