The relative efficacy of codeine 60mg four times daily in improving analgesia for patients following mandibular third molar surgery when augmented to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily: a pilot, double-blind randomized control trial.

Not Applicable

Completed

• Conditions: Postoperative pain following mandibular third molar surgery.; Surgery - Other surgery; Anaesthesiology - Pain management

• Registration Number: ACTRN12613000984796
• Lead Sponsor: Head of the Department of Oral Diagnostic and Surgical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-04
• Study Completion: 2014-12-05
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel of pain. Measured using:<br>1) a visual analogue scale (VAS);<br>2) by means of a participant questionnaire[Each participant records their pain level on a VAS immediately before surgery, shortly after surgery (prior to leaving hospital), and then following surgery every 3 hours for the first 48 hours during awake hours. Each participant also fills out a questionnaire regarding level of pain prior to surgery and also on day 3 following surgery. ]

Secondary Outcome Measures

Name	Time	Method
nil[nil]