Postcraniotomy Pain Clinical Trial
Official title:
Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
| Verified date | May 2015 |
| Source | Tan Tock Seng Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Tan Tock Seng Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Tan Tock Seng Hospital |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr. | 24hr post-op. | No | |
| Secondary | To look at the incidence of adverse events in the oxycodone and codeine groups. | 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. | Up to 72hrs post-op. | Yes |