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Trial registered on ANZCTR


Registration number
ACTRN12611000829910
Ethics application status
Approved
Date submitted
5/08/2011
Date registered
5/08/2011
Date last updated
5/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the safety and efficacy of a morphine-alfentanil mixture versus morphine alone for the management of severe pain in the Emergency Department
Scientific title
In emergency department patients at Lyell McEwin Hospital is a morphine-alfentanil mixture more effective than morphine alone in reducing pain scores
Secondary ID [1] 253297 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain (with a pain severity score rated at greater than or equal to seven out of ten) arising from any cause 258820 0
Condition category
Condition code
Anaesthesiology 258967 258967 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with acute pain with pain scores greater than or equal to 7 will be administered analgesia according to a standard protocol, either receiving the trial medication (a mixture of morphine and alfentanil) or the comparator, morphine alone. The morphine-alfentanil mixture will be in premixed syringes containing 50mcg of alfentanil and 0.75 mg of morphine per millilitre. Patients will be administered bolus doses of one to four millilitres at no less than three minutely intervals until their pain is adequately controlled, provided they do not experience adverse effects or need to be withdrawn from the trial.
Intervention code [1] 257745 0
Treatment: Drugs
Comparator / control treatment
The comparator is a standard treatment for acute pain. We will be using morphine in syringes mixed to 1 mg morphine per millilitre. Patients will be administered bolus doses of 1 to 2.5 millilitres at no less than three minutely intervals until their pain is adequately controlled provided they do not experience adverse effects or need to be withdrawn from the trial.
Control group
Active

Outcomes
Primary outcome [1] 262021 0
The primary outcome will be the time taken to achieve comfort, which has been defined as a pain score of less than or equal to four out of ten.
Timepoint [1] 262021 0
The primary timepoint is once the patient has achieved comfort.
Secondary outcome [1] 268961 0
A secondary outcome is the safety of the trial drug (alfentanil-morphine combination) as compared to standard treatment (morphine alone.) This will be measured by comparing the number of adverse events (nausea, vomiting, pruritis, allergic reaction and opiate toxicity.) The adverse effects will be based on a bedside assessment by the treating doctor and patient reporting of adverse effects. The presence or absence of adverse effect will be recorded on a data sheet.
Timepoint [1] 268961 0
Adverse effects will be monitored for throughout the duration of the study.

Eligibility
Key inclusion criteria
-Patients aged 18 to 70 years (inclusive) with a pain score of greater than or equal to 7.
-Body weight > 50 kg
-patients able to communicate well with the study staff and comply with the study requirements and the study restrictions.
-patients able to understand the Patient Information Sheet and provide a written consent to take part in the study as well as to have a good understanding of the procedure and a good command of English.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-younger than 18 years of age and older than 70 years.
-with known allergies or intolerance, or contradictions to the use of alfentanil, fentanyl or morphine.
-with severe cardiac or respiratory disease (American Society of Anesthesiologists class 4-5),.
-who are opioid tolerant.
-with a history or evidence of drug abuse (including opioids, alcohol, cocaine, benzodiazepines and cannabis), opioid dependence and currently in acute (short lasting) opioid withdrawal.
-who are taking opioid antagonists e.g. naltrexone.
-who are unable to effectively communicate pain using verbal pain scores.
-who have significant cognitive impairment or CNS disturbance.
-who are currently using regularly CNS depressants
-who are taking irreversible monoamine oxidase inhibitors (MAOIs)
-renal impairment (known calculated creatinine clearance of < 75ml/min
-with liver function tests (transaminases) greater than double the normal range.
-who are pregnant or lactating females

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)
Potential participants will be patients admitted to the emergency department with pain scores greater than or equal to 7 out of 10 ( standard ED pain scoring system ), who meet the inclusion criteria detailed below and do not meet the exclusion criteria.

The issue of consent is complex. Because participants will have significant pain at the time of enrollment in the trial, it may be unethical to delay access to effective analgesia for the purposes of obtaining informed consent. Furthermore, patients in acute pain may not be unable to accurately understand the information provided to them and may not have sufficient time to ask questions about the study process prior to the need to administer medication. Obtaining consent from a family member would not always be practical or possible given the time pressures of the situation, and the fact that many patients present without a family member or “significant other.”

Once the patient's pain was adequately controlled the treating medical officer would approach him/her and explain that he/she had been given analgesia of recognized safety and efficacy in treating pain, but also in accordance with a clinical trial to determine relative benefits of the two drugs/ drug mixtures used in the trial. The medical officer would provide a patient information sheet and request consent to use the patient's data in the trial.

The allocation to the treatment groups will be determined by pharmacy supplying syringes of either an alfentanil-morphine mixture or morphine alone based on a computer based randomisation. The treating nurse will administer the medication from the syringe, and will be blinded to the contents of that syringe by virtue of the syringes being identical to each other.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used to randomise patients to each arm of the study.

Pharmacy will supply syringes containing either morphine or alfentanil-morphine mixture based on a computer-generated randomisation. The syringes will be supplied in “batches” of a quantity predetermined by Pharmacy. Supplying individual syringes will not be possible as a single patient may require more than one syringe to achieve adequate analgesia. Supplying the syringes in “batches” will ensure that if a patient requires additional syringes he/she will continue to receive the same type of syringe. Batches are to be changed twice weekly (not alternated, but as determined by pharmacy to ensure randomization.)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258393 0
University
Name [1] 258393 0
The University of Adelaide
Country [1] 258393 0
Australia
Primary sponsor type
Individual
Name
Dr. Adrianne Boonstra
Address
c/o Emergency Department
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA
5112
Country
Australia
Secondary sponsor category [1] 257534 0
Individual
Name [1] 257534 0
Dr. Joy Treasure
Address [1] 257534 0
c/o Emergency Department
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA
5112
Country [1] 257534 0
Australia
Secondary sponsor category [2] 266641 0
Individual
Name [2] 266641 0
Dr. Alison Kent
Address [2] 266641 0
c/o Emergency Department
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA
5112
Country [2] 266641 0
Australia
Other collaborator category [1] 251784 0
Individual
Name [1] 251784 0
Dr. Jennifer Ong
Address [1] 251784 0
Department of Anaesthesia
Royal Adelaide Hospital
Adelaide, SA
5000
Country [1] 251784 0
Australia
Other collaborator category [2] 252176 0
Individual
Name [2] 252176 0
Professor Guy Ludbrook
Address [2] 252176 0
Royal Adelaide Hospital
Adelaide, SA
5000
Country [2] 252176 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 32015 0
Address 32015 0
Country 32015 0
Phone 32015 0
Fax 32015 0
Email 32015 0
Contact person for public queries
Name 15262 0
Dr. Adrianne Boonstra
Address 15262 0
c/o Emergency Department
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA
5112
Country 15262 0
Australia
Phone 15262 0
+61 8 8182-9279
Fax 15262 0
+61 8 8182-9179
Email 15262 0
adrianne.boonstra@health.sa.gov.au
Contact person for scientific queries
Name 6190 0
Dr. Adrianne Boonstra
Address 6190 0
c/o Emergency Department
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA
5112
Country 6190 0
Australia
Phone 6190 0
+61 8 8182-9279
Fax 6190 0
+61 8 8182-9179
Email 6190 0
adrianne.boonstra@health.sa.gov.au

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.