Efficacy of different over-the-counter analgesics for postoperative pain following oral biopsy
| ISRCTN | ISRCTN70034520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70034520 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | King Abdulaziz University |
| Funder | King Abdulaziz University |
- Submission date
- 26/09/2025
- Registration date
- 26/09/2025
- Last edited
- 26/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Oral biopsies are small surgical procedures often needed to diagnose problems in the mouth. These procedures can cause pain afterwards. Many patients are treated with common painkillers such as paracetamol (acetaminophen) or ibuprofen, but it is not clear which works best. This study aimed to find out which commonly available medicine controls post-biopsy pain most effectively.
Who can participate?
Adult patients scheduled for an oral biopsy at King Abdulaziz University Dental Hospital in Jeddah, Saudi Arabia.
What does the study involve?
Participants were randomly placed into one of the three groups:
1. Paracetamol (1000 mg)
2. Ibuprofen (600 mg)
3. A combination tablet containing paracetamol (1000 mg), caffeine (60 mg), and codeine (18 mg).
Participants took the medication for 72 hours after their biopsy. Pain was measured at 4, 24, and 48 hours after the procedure using a standard 0–10 pain scale.
What are the possible benefits and risks of participating?
Benefits and risks not provided at registration.
Where is the study run from?
Faculty of Dentistry, King Abdul Aziz University, Saudi Arabia.
When is the study starting and how long is it expected to run for?
April 2027 to March 2025
Who is funding the study?
Faculty of Dentistry, King Abdul Aziz University, Saudi Arabia.
Who is the main contact?
Dr Sara Akeel, sakeel@kau.edu.sa
Contact information
Public, Scientific, Principal investigator
King Abdulaziz University
Alsulaimanyah
Jeddah
21589
Saudi Arabia
 ORCID ID |
0000-0001-8006-1185 |
|---|---|
| Phone | +966126952000 |
| sakeel@kau.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional quasi-experimental parallel-group open-label study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Efficacy of different over-the-counter analgesics for postoperative pain following oral biopsy: a quasi-experimental study |
| Study objectives | The objective of this study was to determine the efficacy of different OTC medications in the management of postoperative pain following oral biopsy to provide high-quality evidence on optimal first-line analgesia for patients following oral biopsies |
| Ethics approval(s) |
Approved 25/12/2017, Research Ethics Committee, Faculty of Dentistry, King Abdul Aziz University (Alsuliamania, Jeddah, 21589, Saudi Arabia; +966126403443; den.faculty@kau.edi.sa), ref: 055-05-17 |
| Health condition(s) or problem(s) studied | Postoperative pain following oral mucosal biopsy |
| Intervention | Patients will receive the following treatment for postoperative pain following oral mucosal biopsy: Group A: Acetaminophen 1000 mg every 6 hours Group B: Ibuprofen 600 mg every 6 hours Group C: Combination acetaminophen 1000 mg + caffeine 60 mg + codeine 18 mg every 6 hours Treatment duration: 72 hours post-biopsy A comparative analysis of outcome variable pain scores will be undertaken between intervention groups at each time point (including post-hoc pairwise comparisons). |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acetaminophen, ibuprofen, caffeine, codeine |
| Primary outcome measure(s) |
Postoperative pain intensity measured using a Visual Analog Scale (VAS, 0–10) at 4, 24, and 48 hours after the biopsy procedure |
| Key secondary outcome measure(s) |
Incidence of medication side effects or adverse events measured using data collected in Case Report Forms during the 72-hour treatment period |
| Completion date | 13/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 75 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Adults (18–90 years) 2. Scheduled for oral biopsy at KAU-FD 3. Capacity to judge pain |
| Key exclusion criteria | 1. Patients with pain at baseline 2. Currently on pain or mood-altering medications 3. Allergic to any of the medications |
| Date of first enrolment | 30/04/2018 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Jeddah
21589
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analyses during the current study will be available upon request from Dr Sara Akeel, sakeel@kau.edu.sa |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/09/2025: Study's existence confirmed by the Research Ethics Committee, Faculty of Dentistry, King Abdul Aziz University, Saudi Arabia.
