Cleft Palate RepairPhase 4NCT00386269
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
A Phase 4 study testing Codeine Phosphate Analgesia in people with Cleft Palate Repair, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary. Read more about this study
- Who is it for?
- Ages 4 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate Repair
- What is being tested?
- Codeine Phosphate Analgesia
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Sep 2007
- 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 4 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with cleft palate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital, Anaesthetics
London, WC1N 1EH
About this study
This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.
- Conditions
- Cleft Palate Repair
- Being tested
- Codeine Phosphate Analgesia
- Keywords
- codeine phosphate analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Codeine Phosphate AnalgesiaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of morphine used within the first 6h after surgery
Secondary outcomes (1)
Pain scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startJan 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate RepairStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Mike Sury, Dr, Principal investigator, Institute Of Child Health and Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386269
- Sponsor's protocol ID
- 02AR53
- Status last verified
- Nov 2007
- First submitted
- 10 Oct 2006
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
- ClinicalTrials.gov ID
- NCT00386269
- Acronym / sponsor ID
- 02AR53
- Conditions
- Cleft Palate Repair
- Keywords
- codeine phosphate analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 11 Oct 2006 (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.
This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with cleft palate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Codeine Phosphate Analgesia | Drug | – |
Primary outcome
Dose of morphine used within the first 6h after surgery
1 secondary outcome
Pain scores
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 29 Nov 2007.
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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.
Mike Sury, Dr principal investigator
Institute Of Child Health and Great Ormond Street Hospital
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 Codeine Phosphate Analgesia in people with Cleft Palate Repair, run by Institute of Child Health at 1 site in United Kingdom.
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 1 inclusion and 0 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 29 Nov 2007. 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 United Kingdom. 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?
Dose of morphine used within the first 6h after surgery. 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 29 Nov 2007.