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

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ClinicalTrials.gov Identifier: NCT01672112
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Lim Pei-Pei Mandy, Tan Tock Seng Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postcraniotomy Pain Drug: Oxycodone Drug: Codeine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Study Start Date : July 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672112


Locations
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Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
More Information
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Responsible Party: Lim Pei-Pei Mandy, Consultant, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01672112    
Other Study ID Numbers: 2011/02076
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015
Keywords provided by Lim Pei-Pei Mandy, Tan Tock Seng Hospital:
analgesic efficacy
oral codeine
oral oxycodone
postcraniotomy
Additional relevant MeSH terms:
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Oxycodone
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents