DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017