Postcraniotomy PainPhase 4NCT01672112
Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
A Phase 4 study testing Oxycodone and Codeine in people with Postcraniotomy Pain, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Postcraniotomy Pain
- What is being tested?
- Oxycodone and Codeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2012to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Postcraniotomy Pain
- Being tested
- Oxycodone, Codeine
- Keywords
- analgesic efficacy, oral codeine, oral oxycodone, postcraniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxynorm Immediate Release
Oral Oxycodone 5mg 6hrly/prn
CodeineDrug
Also called Codeine Phosphate
Oral Codeine 60mg 6hrly/prn
| Study group | Role | What they receive |
|---|---|---|
| Codeine | Other | Oral Codeine 60mg 6hrly/prn Receives: Drug: Codeine |
| Oxycodone | Active comparator | Oral Oxycodone 5mg 6hrly/prn Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.
Measured: 24hr post-op.
Secondary outcomes (1)
To look at the incidence of adverse events in the oxycodone and codeine groups.
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.
Measured: Up to 72hrs post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postcraniotomy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lim Pei-Pei Mandy, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672112
- Sponsor's protocol ID
- 2011/02076
- Status last verified
- May 2015
- First submitted
- 21 Aug 2012
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
- ClinicalTrials.gov ID
- NCT01672112
- Acronym / sponsor ID
- 2011/02076
- Conditions
- Postcraniotomy Pain
- Keywords
- analgesic efficacy, oral codeine, oral oxycodone, postcraniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Codeine | Other | Drug: CodeineOral Codeine 60mg 6hrly/prn |
| Oxycodone | Active comparator | Drug: OxycodoneOral Oxycodone 5mg 6hrly/prn |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneAlso: Oxynorm Immediate ReleaseOral Oxycodone 5mg 6hrly/prn | Drug | Oxycodone |
| CodeineAlso: Codeine PhosphateOral Codeine 60mg 6hrly/prn | Drug | Codeine |
Primary outcome
To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.
Time frame: 24hr post-op.
1 secondary outcome
To look at the incidence of adverse events in the oxycodone and codeine groups.
Time frame: Up to 72hrs post-op.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone and Codeine in people with Postcraniotomy Pain, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr. (time frame: 24hr post-op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.