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
Study website
Contact information
Type
Scientific
Contact name
Dr Majd Almutairi
ORCID ID
Contact details
Taibah University College of Dentistry
Prince Naif road
Almadinah
42353
Saudi Arabia
+966 148618332
information@taibahudental.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
TUCDREC/20180102/Alaufi
Study information
Scientific title
Roxonin versus Rabidus in post-dental extraction pain relief and side effects: a randomized, triple-blind, controlled clinical trial
Acronym
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
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
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 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 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
Taibah University College of Dentistry
Prince Naif Road
Almadinah
42353
Saudi Arabia
Sponsor information
Organisation
Taibah University College of Dentistry
Sponsor details
Prince Naif road
Almadinah
42353
Saudi Arabia
+966 14-8618888
information@taibahudental.com
Sponsor type
Government
Website
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
20/12/2019
Individual participant data (IPD) sharing plan
All data generated or analysed during this study will be included in the subsequent results publication
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/12/2019 | 03/01/2023 | Yes | No |