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

This study has been completed.
Information provided by (Responsible Party):
Lim Pei-Pei Mandy, Tan Tock Seng Hospital Identifier:
First received: August 21, 2012
Last updated: May 13, 2015
Last verified: May 2015

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.

Condition Intervention Phase
Postcraniotomy Pain
Drug: Oxycodone
Drug: Codeine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

Resource links provided by NLM:

Further study details as provided by Tan Tock Seng Hospital:

Primary Outcome Measures:
  • To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr. [ Time Frame: 24hr post-op. ]

Secondary Outcome Measures:
  • To look at the incidence of adverse events in the oxycodone and codeine groups. [ Time Frame: 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.

Enrollment: 40
Study Start Date: July 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oral Codeine 60mg 6hrly/prn
Drug: Codeine
Oral Codeine 60mg 6hrly/prn
Other Name: Codeine Phosphate
Active Comparator: Oxycodone
Oral Oxycodone 5mg 6hrly/prn
Drug: Oxycodone
Oral Oxycodone 5mg 6hrly/prn
Other Name: Oxynorm Immediate Release


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01672112

Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
  More Information

Responsible Party: Lim Pei-Pei Mandy, Consultant, Tan Tock Seng Hospital Identifier: NCT01672112     History of Changes
Other Study ID Numbers: 2011/02076
Study First Received: August 21, 2012
Last Updated: May 13, 2015

Keywords provided by Tan Tock Seng Hospital:
analgesic efficacy
oral codeine
oral oxycodone

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on May 25, 2017