Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000118303
Ethics application status
Approved
Date submitted
26/02/2008
Date registered
5/03/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double-blinded Randomised Evaluation of Alfentanil and Morphine versus Fentanyl: Analgesia and Sleep Trial.
Scientific title
In post-operative patients, is a combination of alfentanil and morphine as good as or better than fentanyl at providing analgesia adequate to prevent pain-related waking from sleep.
Secondary ID [1] 252668 0
Nil
Universal Trial Number (UTN)
Trial acronym
DREAMFAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Analgesia 2867 0
Post-operative Sleep 2868 0
Condition category
Condition code
Anaesthesiology 3004 3004 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined alfentanil 0.075mg and morphine 1.0 mg per ml of solution, administered by patient via Patient Controlled Intravenous Analgesia (PCIA) device programmed to deliver 1ml boluses with a 5 minute lockout, for 2 nights or until conversion to oral analgesia is appropriate.
Intervention code [1] 2598 0
Treatment: Drugs
Comparator / control treatment
Standard treatment at Sir Charles Gairdner Hospital; fentanyl 20mcg per ml of solution, administered by patient via Patient Controlled Intravenous Analgesia (PCIA) device programmed to deliver 1ml boluses with a 5 minute lockout, for 2 nights or until conversion to oral analgesia is appropriate.
Control group
Active

Outcomes
Primary outcome [1] 3886 0
Number of pain related awakenings on the second post-operative night, as self-reported by patients the following morning on the trial questionnaire (modified St Mary's Hospital Sleep Questionnaire)
Timepoint [1] 3886 0
Second post-operative morning
Secondary outcome [1] 6528 0
Sleep quality as subjectively rated by patients via Likert Scale on the trial questionnaire (modified St Mary's Hospital Sleep Questionnaire)
Timepoint [1] 6528 0
Second post-operative morning

Eligibility
Key inclusion criteria
Patients scheduled to undergo inpatient surgery where Patient-Controlled Intravenous Analgesia is indicated post-operatively, who are capable of providing informed consent, understanding how to use the PCIA device and activating the PCIA device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American Society of Anesthesiologists (ASA) Physical status 4 or 5, renal or hepatic failure, obstructive sleep apnoea requiring treatment, allergy to morphine, alfentanil or fentanyl, history of opioid abuse or chronic opioid use, inability to use the PCIA device, inability to complete the questionnaire, use of a continuous regional analgesic technique, previous participation in this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation after consent and enrollment is via a computer generated randomisation list held by pharmacy, in order of enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 589 0
6009

Funding & Sponsors
Funding source category [1] 3121 0
Hospital
Name [1] 3121 0
Sir Charles Gairdner Hospital Department of Anaesthesia
Country [1] 3121 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 2809 0
None
Name [1] 2809 0
Address [1] 2809 0
Country [1] 2809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5098 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 5098 0
Hospital Ave
Nedlands WA 6009
Ethics committee country [1] 5098 0
Australia
Date submitted for ethics approval [1] 5098 0
Approval date [1] 5098 0
19/12/2007
Ethics approval number [1] 5098 0
2007-117

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28400 0
Address 28400 0
Country 28400 0
Phone 28400 0
Fax 28400 0
Email 28400 0
Contact person for public queries
Name 11557 0
Dr Angeline Lee
Address 11557 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 11557 0
Australia
Phone 11557 0
+61 8 93463011
Fax 11557 0
Email 11557 0
[email protected]
Contact person for scientific queries
Name 2485 0
Dr Angeline Lee
Address 2485 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 2485 0
Australia
Phone 2485 0
+61 8 93463011
Fax 2485 0
Email 2485 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.