Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Information source: Tan Tock Seng Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postcraniotomy Pain
Intervention: Oxycodone (Drug); Codeine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tan Tock Seng Hospital
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.
Clinical Details
Official title: Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.
Secondary outcome: To look at the incidence of adverse events in the oxycodone and codeine groups.
Eligibility
Minimum age: 21 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Tan Tock Seng Hospital, Singapore 308433, Singapore
Additional Information
Starting date: July 2012
Last updated: May 13, 2015
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