None listed
Conditions
Brief summary
The proposed study aims to determine whether codeine pain relief medication is necessary in addition to paracetamol and ibuprofen pain relief medications following wisdom teeth surgery. This study, therefore, may prove beneficial to dentists, oral surgeons, and oral-and-maxillofacial surgeons, and ultimately to their patients, in regard to postoperative pain management for wisdom teeth surgery. For example, if the proposed study demonstrates that codeine is not a statistically significant supplement to the paracetamol ibuprofen combination for adequate pain relief following wisdom teeth surgery, then patients may benefit by not being unnecessarily subjected to the risk of greater side effects associated with codeine. Conversely, the study may find that codeine is indeed statistically significant, thereby providing clinicians with scientific evidence that in order to attain adequate pain relief after wisdom teeth surgery it is advisable to add codeine to the paracetamol ibuprofen regime.
Interventions
Intervention group:
paracetamol 1000mg four times daily (qid) + ibuprofen 400mg three times daily (tds) + codeine phosphate 60mg qid.
Mode of administration is oral.
Duration of intervention is 48 hours following surgery.
Participants will be asked regarding their adherence to the prescribed drug regime as part of the post-operative questionnaire on day 3 following surgery.
Sponsors
Head of the Department of Oral Diagnostic and Surgical Sciences
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The patient must be aged 17 years or over. There will be no discrimination (e.g. gender; race; ethnicity). Moreover, non-English speaking people will not be excluded; an accredited interpreter will be employed per required need. Patient participation is entirely voluntary. Patients must have been seen by a consultant oral and maxillofacial surgeon at the University of Otago, or by one of their oral and maxillofacial surgery trainees, and be deemed appropriate for participation in the present study by this clinician. The patient must legitimately require at least the removal of one or both of their mandibular third molars. Expected bone removal for extraction of the mandibular third molar(s).
Exclusion criteria
Patients under 17 years of age are not eligible for participation in this research project. This is to provide a safeguard around the level of drug doses used. The patient must not have any of the following conditions or reasons which contraindicate or caution the use of paracetamol, ibuprofen, or codeine, as described in the latest edition of MIMS New Ethicals: Anyone who needs to drive a motor vehicle or operate machinery within the 48 hour period following surgery NSAID-sensitive asthma Active gastrointestinal bleeding or ulceration Bleeding disorder Patients on anticoagulants P Renal impairment Hepatic impairment Cardiovascular disease Systemic lupus erythematosus Patients on hepatic enzyme inducers (e.g. certain anticonvulsants) Pregnancy and lactation Respiratory depression; COPD Raised intracranial pressure Alcoholism Opioid addiction Patients on CNS depressants G-6-PD deficiency Hypersensitivity to morphine Furthermore, the patient must not have any of the following conditions or reasons which contraindicate or caution the use of midazolam or dexamethasone, as described in the latest edition of MIMS New Ethicals: Hypersensitivity to benzodiazepines Myasthenia gravis Glaucoma Systemic viral, bacterial, or fungal infection Osteoporosis Psychosis Finally, the patient must not have a contraindication to either intravenous sedation or general anaesthetic.
Outcome results
None listed