Loxoprofen versus diclofenac potassium in post-dental extraction pain relief and side effects
| ISRCTN | ISRCTN62004181 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62004181 |
| Secondary identifying numbers | TUCDREC/20180102/Alaufi |
- Submission date
- 04/11/2019
- Registration date
- 05/11/2019
- Last edited
- 03/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Tooth extraction remains one of the common procedures in developing countries. However, one of a common postoperative complication of extraction is severe pain, so it is important to prescribe some analgesic to relief that pain. The aim of this study is to compare between two commonly prescribed oral analgesics in our country (Saudi Arabia) for reducing pain after tooth extraction with the least side effects (Roxonin , Rabidus).
Who can participate?
Participants over the age of 18, undergoing tooth extraction at the study site
What does the study involve?
Pain assessment was carried out postoperatively by 6 hours and every 12 hours for 3 days using visual analogue scale
What are the possible benefits and risks of participating?
Benefits: reducing post-extraction pain by receiving free analgesics.
Risks: There are no direct risks. If there is an allergy to the treatment the participant will be stopped immediately.
Where is the study run from?
Taibah University College of Dentistry, Saudi Arabia
When is the study starting and how long is it expected to run for?
January 2018 to March 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Majd Almutairi
m.rja_almutairi@hotmail.com
Contact information
Scientific
Taibah University College of Dentistry
Prince Naif road
Almadinah
42353
Saudi Arabia
| Phone | +966 148618332 |
|---|---|
| information@taibahudental.com |
Study information
| Study design | Interventional single-centre triple-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Roxonin versus Rabidus in post-dental extraction pain relief and side effects: a randomized, triple-blind, controlled clinical trial |
| Study hypothesis | There will be no difference between Rabidus and Rexonin oral analgesics for controlling post-dental extraction pain and side effects (e.g. vomiting). |
| Ethics approval(s) | Approved 13/02/2019, Taibah University College of Dentistry Research Ethics Committee (Prince Naif Road, Almadinah, 42353, Saudi Arabia; amramadan@taibahu.edu.sa), ref: TUCDREC/20180102/Alaufi |
| Condition | Pain after tooth extraction |
| Intervention | Eligible patients after tooth extraction were randomized to the study interventional groups (Rapidus or Roxonin) by means of drawing lots and intervention and control were coded as A or B. The codes of the drugs were kept by an independent monitor and were unveiled until all data underwent analyses. The researcher, the clinicians, and patients were blinded to the codes of the drugs A and B during the course of the study. When the participant opens the envelope, he/she found the instruction of how to take the medicine as the manufacture instructed. Medicine was taken for three days and pain assessed by VAS after 6 hours and then every 12 hours for three days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Roxonin (Loxoprofen) Rabidus (Diclofenac Potassium) |
| Primary outcome measure | Pain after tooth extraction by using VAS (visual analogue scale) , the timepoint was after 6 hours of tooth extraction and every 12 hours for three days. |
| Secondary outcome measures | Side effects over the trial period (three days) |
| Overall study start date | 01/01/2018 |
| Overall study end date | 01/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Participant inclusion criteria | 1. Age 18-70 years old . 2. Literate people (speaking, reading and writing Arabic or English). 3. Healthy or with controlled systemic disease as recommended by the American Society of Anesthesiologists and had no risk from the administration of LA with adrenaline (hyperthyroidism). |
| Participant exclusion criteria | 1. Could not give informed consent (e.g. mental disorder) 2. Teeth with reversible pulpitis 3. History of taking anticoagulant, active peptic ulcer and attack of asthma |
| Recruitment start date | 20/01/2018 |
| Recruitment end date | 24/03/2018 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Almadinah
42353
Saudi Arabia
Sponsor information
Government
Prince Naif road
Almadinah
42353
Saudi Arabia
| Phone | +966 14-8618888 |
|---|---|
| information@taibahudental.com | |
| Website | https://www.taibahu.edu.sa |
"ROR" |
https://ror.org/01xv1nn60 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/12/2019 | 03/01/2023 | Yes | No |
Editorial Notes
03/01/2023: Publication reference and total final enrolment added.
11/11/2019: The Phase was changed from II to IV.
07/11/2019: Internal review.
05/11/2019: Trial’s existence confirmed by Taibah University College of Dentistry Research Ethics Committee
