Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
NCT ID: NCT01672112
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2012-07-31
2015-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Codeine
Oral Codeine 60mg 6hrly/prn
Codeine
Oral Codeine 60mg 6hrly/prn
Oxycodone
Oral Oxycodone 5mg 6hrly/prn
Oxycodone
Oral Oxycodone 5mg 6hrly/prn
Interventions
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Oxycodone
Oral Oxycodone 5mg 6hrly/prn
Codeine
Oral Codeine 60mg 6hrly/prn
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned elective craniotomy
* ASA 1-3
* GCS 15 pre and post-op
* Able to understand and use the visual analogue scale
Exclusion Criteria
* 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.
21 Years
70 Years
ALL
No
Sponsors
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Tan Tock Seng Hospital
OTHER
Responsible Party
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Lim Pei-Pei Mandy
Consultant
Locations
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Tan Tock Seng Hospital
Singapore, Singapore, Singapore
Countries
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Other Identifiers
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2011/02076
Identifier Type: -
Identifier Source: org_study_id
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