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

This study is currently recruiting participants.
Verified August 2012 by Tan Tock Seng Hospital
Sponsor:
Information provided by (Responsible Party):
Lim Pei-Pei Mandy, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01672112
First received: August 21, 2012
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To look at the incidence of adverse events in the oxycodone and codeine groups. [ Time Frame: Up to 72hrs post-op. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Codeine
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672112

Contacts
Contact: Mandy Lim, M.Med Anesthesiology +65 81263574 mandy_lim@ttsh.com.sg

Locations
Singapore
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Contact: Mandy Lim, M.Med Anesthesiology     +65 81263574     mandy_lim@ttsh.com.sg    
Sponsors and Collaborators
Tan Tock Seng Hospital
  More Information

No publications provided

Responsible Party: Lim Pei-Pei Mandy, Consultant, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01672112     History of Changes
Other Study ID Numbers: 2011/02076
Study First Received: August 21, 2012
Last Updated: August 23, 2012
Health Authority: Singapore: Health Sciences Authority

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

Additional relevant MeSH terms:
Codeine
Oxycodone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013