None listed
Conditions
Brief summary
The aim of this study is to compare the pre-operative effectiveness of two different types of anti-inflammatory painkillers on pain, swelling, and mouth opening after wisdom teeth surgery. It will also compare whether there are any differences in the need for extra painkillers and any side effects encountered. The medications involved in this project are etoricoxib (Arcoxia) 120mg and sustained-release ibuprofen 1.6g, two commonly used painkillers. To help minimise bias, neither the researcher nor the participants will know which participants are receiving which medication. The medication will be given 2 hours before the wisdom teeth surgery. Pre-operative etoricoxib (Arcoxia) 120mg will have a better effect in reducing post-operative pain over sustained-release ibuprofen 1.6g. The effect on post-operative swelling and mouth opening will be similar for both etoricoxib (Arcoxia) 120mg and sustained-release ibuprofen 1.6g.
Interventions
Etoricoxib 120mg capsule
- Etoricoxib 120mg will be prepared in 4 capsules in divided doses (each capsule will contain 30mg of etoricoxib)
I.e. all 4 capsules of etoricoxib (120mg) will be administered orally as a single dose 2 hours pre-operatively under direct supervision/observation by the principal researcher
Sponsors
Faculty of Dentistry, University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
All prospective participants must be seen by the principal investigator with the guidance from a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago. i. Patients must be deemed appropriately suitable for participation in the present study by the principal investigator or a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago. ii. The participant must be aged between 18 and 35 years. iii. The participant must legitimately require removal of at least two mandibular third molars (and may require removal of maxillary third molar/s) as per third molar surgical protocol at the School of Dentistry, University of Otago. iv. Expected bone removal and/or tooth sectioning for extraction of the impacted bilateral mandibular third molars. v. The participant must be medically fit (American Society of Anaesthesiologist (ASA) physical status classification 1 or 2) to have their third molars removed. vi. The participant must be assessed as appropriate for an intravenous (IV) sedation. vii. The participant must consent to having their third molars removed under IV sedation and local anaesthesia. viii. There will be no discrimination based on gender, race, and ethnicity. Non-English-speaking patients will be given equal opportunity to participate; an accredited interpreter will be employed as required.
Exclusion criteria
i. Patients under the age of 18 years and over 35 years of age ii. Patients are excluded if they meet any of the following criteria: 1. Any significant systemic disease/s classified as ASA 3, 4, or 5 2. Active/history of gastrointestinal bleeding or ulceration 3. Currently pregnant or lactating 4. Body weight >120kg 5. Cardiovascular disease classified under ASA 3, 4, or 5 6. Non-steroidal anti-inflammatory drug (NSAID)-sensitive asthma 7. Respiratory depression, chronic obstructive pulmonary disease 8. Hepatic impairment 9. Renal impairment 10. Bleeding disorders 11. Therapeutic anticoagulation 12. Bone disorders 13. Metabolic diseases 14. Patients of bisphosphonates 15. Patients on long-term benzodiazepines, opioids, and liver enzyme induction agents/medications 16. Hypersensitivity to benzodiazepines, etoricoxib, ibuprofen, and codeine phosphate 17. Use of NSAIDs within 48 hours prior to the day of surgery 18. Presence of swelling, fever, trismus prior to third molar surgery 19. Opioid and illicit drug addiction 20. Alcoholism 21. Current smokers who refuse to stop smoking within 72 hours following third molar surgery 22. Patients opting to undergo third molar surgery under local or general anaesthesia 23. Patients unable to give informed consent iii. Patients who have third molars with following: 1. Associated pathologies 2. Third molar/s requiring coronectomy 3. Third molars with higher risk of mandibular fracture 4. Maxillary third molar/s with higher risk of oro-antral communication 5. Oral surgery requiring more than four third molars extracted
Outcome results
None listed