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

NCT01672112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-15

No results posted yet for this study

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.

Conditions

  • Postcraniotomy Pain

Interventions

DRUG

Oxycodone

Oral Oxycodone 5mg 6hrly/prn

DRUG

Codeine

Oral Codeine 60mg 6hrly/prn

Sponsors & Collaborators

  • Tan Tock Seng Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01672112 on ClinicalTrials.gov