Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

Sponsors

Lead sponsor: Tan Tock Seng Hospital

Source 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.

Overall Status Completed
Start Date July 2012
Completion Date January 2015
Primary Completion Date January 2015
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr. 24hr post-op.
Secondary Outcome
Measure Time Frame
To look at the incidence of adverse events in the oxycodone and codeine groups. Up to 72hrs post-op.
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: Oxycodone

Description: Oral Oxycodone 5mg 6hrly/prn

Arm group label: Oxycodone

Other name: Oxynorm Immediate Release

Intervention type: Drug

Intervention name: Codeine

Description: Oral Codeine 60mg 6hrly/prn

Arm group label: Codeine

Other name: Codeine Phosphate

Eligibility

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.

Gender: All

Minimum age: 21 Years

Maximum age: 70 Years

Healthy volunteers: No

Location
facility Tan Tock Seng Hospital
Location Countries

Singapore

Verification Date

May 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Tan Tock Seng Hospital

Investigator full name: Lim Pei-Pei Mandy

Investigator title: Consultant

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Codeine

Arm group type: Other

Description: Oral Codeine 60mg 6hrly/prn

Arm group label: Oxycodone

Arm group type: Active Comparator

Description: Oral Oxycodone 5mg 6hrly/prn

Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov