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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01672112

Enrollment

Registered

2012-08-24

Start date

2012-07-31

Completion date

2015-01-31

Last updated

2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postcraniotomy Pain

Keywords

analgesic efficacy, oral codeine, oral oxycodone, postcraniotomy

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.

Interventions

DRUGOxycodone

Oral Oxycodone 5mg 6hrly/prn

DRUGCodeine

Oral Codeine 60mg 6hrly/prn

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame	Description
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.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026