Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
- Registration Number
- NCT01672112
- Lead Sponsor
- Tan Tock Seng Hospital
- Brief Summary
The efficacy of codeine is dependent on its demethylation to morphine. This extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.
Codeine has been the mainstay of analgesia for patients after craniotomy for many years. Traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine).
However, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction.
No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine.
Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Ages 21-70 years of age
- Planned elective craniotomy
- ASA 1-3
- GCS 15 pre and post-op
- Able to understand and use the visual analogue scale
- Patients with GCS < 15 pre and/or post-op.
- Patients who are unable to quantify pain according to VAS scale.
- Patients who will be left intubated post-op.
- Contraindications and/or allergies to any of the trial drugs.
- Patients with renal and/or hepatic impairment.
- Patients with decreased respiratory reserves.
- Patients with post-op cognitive dysfunction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Codeine Codeine Oral Codeine 60mg 6hrly/prn Oxycodone Oxycodone Oral Oxycodone 5mg 6hrly/prn
- Primary Outcome Measures
Name Time Method To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr. 24hr post-op.
- Secondary Outcome Measures
Name Time Method To look at the incidence of adverse events in the oxycodone and codeine groups. Up to 72hrs post-op. To compare the incidence of excessive sedation, respiratory depression and GCS; to compare the pain VAS scores at 48 and 72hrs post-op; to compare the mean satisfaction scores at 24 and 72hrs post-op.
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore