Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000588099
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
21/07/2010
Date last updated
26/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effectiveness of three oral analgesic combinations in adults presenting to the Emergency Department with moderate pain from acute limb injury.
Scientific title
A double blind randomised controlled trial assessing the analgesic equivalency of oxycodone, paracetamol and ibuprofen with codeine, paracetamol and ibuprofen or paracetamol and ibuprofen alone in moderate pain from musculoskeletal limb injuries presenting to the emergency department.
Secondary ID [1] 251936 0
No secondary ID present
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
analgesia 257508 0
moderate pain 257509 0
comparative analgesic effectiveness 257510 0
emergency medicine 257511 0
Condition category
Condition code
Injuries and Accidents 257669 257669 0 0
Other injuries and accidents
Anaesthesiology 257683 257683 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1) oxycodone 10 mg oral tablet with paracetamol 1000 mg oral tablet with ibuprofen 400 mg oral tablet administered simultaneously as a single dose
Arm 2) codeine 60 mg oral tablet with paracetamol 1000 mg oral tablet with ibuprofen 400 mg oral tablet administered simultaneously as a single dose
Intervention code [1] 256603 0
Treatment: Drugs
Comparator / control treatment
paracetamol 1000 mg oral tablet with ibuprofen 400 mg oral tablet with thiamine 200 mg oral tablet as a single dose
Control group
Active

Outcomes
Primary outcome [1] 258575 0
Minimum fall in pain score of at least 20 mm on 100 mm visual analog scale from baseline pain score taken at triage.
Timepoint [1] 258575 0
Change in pain score from baseline compared to pain scores at 15, 30, 45 and 60 minutes post analgesia adminstration
Secondary outcome [1] 264436 0
Use of rescue analgesia as assessed by lack of fall in pain score on visual analog scale administered by study researcher
Timepoint [1] 264436 0
60 minutes post-analgesia administration
Secondary outcome [2] 264481 0
Patient satisfaction with analgesia regimen assessed at end of study period by study researcher asking subject the degree of satisfaction on a three point satisfaction scale: 1) satisfied 2) not satisfied 3) unsure
Timepoint [2] 264481 0
60 minutes post-analgesia administration
Secondary outcome [3] 264482 0
Patient ability to indentify drug regimen prescribed to them. Subjects will be asked by a study investigator whether they think they received:
1) Paracetamol Ibuprofen and Thiamine
2) Paracetamol Ibuprofen and Oxycodone
3) Paracetamol Ibuprofen and Codeine
Timepoint [3] 264482 0
60 minutes post-analgesia administration

Eligibility
Key inclusion criteria
1) Adult patients greater than or equal to18 years old and less than or equal to 75 years old AND
2) Limb injury within the preceding 48 hours AND
3) Initial verbal pain score elicited by the Triage Nurse of greater than 3/10 to less than or equal to 7/10 (ie 4 to 7/10)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Need for any time critical interventions (e.g. reduction of dislocations or compound fractures) .

Digital injuries (pain from these should ideally be treated with digital block).

Pregnant and breastfeeding women (paracetamol and codeine are Category A drugs but Ibuprofen and oxycodone are Category C; with regard to lactation, paracetamol and ibuprofen are considered safe, but codeine and oxycodone are not recommended).

Asthma that may be Non-Steroidal Anti-inflammatory Drug (NSAID) sensitive.

Active peptic ulcer disease.

Known renal impairment.

Ethanol or recreational drug abuse or acute intoxication.

Use of any analgesic or sedating agent in the preceding 4 hours .

Regular use of analgesic agents for chronic pain.

Inability to take oral analgesics.

Known allergy or intolerance to paracetamol, to any opiate, or to any NSAID including Aspirin.

Patients not willing to comply with the recommendation not to drive, consume alcohol or operate machinery for at least 8 hours after being given the study drug combination.

Patients unable to understand the study explanation or unwilling to participate for whatever reason.

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)
The Triage Nurse in the emergency department will ask all patients with isolated limb injury for a 0-10 pain rating in the usual way. When the rating is greater than 3 and less than or equal to 7 and the patient appears otherwise eligible, the Triage Nurse will inform the SRO who will assess the patient for eligibility as soon as possible and will obtain informed consent where eligibility is confirmed.

Study recruitment officers will include Emergency Physicians, medical students, pharmacists and other trained doctors working in the ED. They will recruit the convenience sample of patients that meet the inclusion criteria and without exclusion criteria.

We will endeavor to flag potential participants using our electronic triage and patient tracking system in concert with the Triage Nurse. This will alert clinicians to potential subjects and also help us retrospectively determine numbers of potential subjects not approached for trial consideration given various constraints of the ED setting.

If the SRO, for whatever reason, believes that study recruitment will be delayed for more than fifteen minutes, then the SRO will tell the Triage Nurse that timely recruitment is not going to be possible and that nurse initiated analgesia should be instituted as per protocol.

On obtaining informed consent, the SRO/treating doctor will order the study medication on a standard hospital medication chart. The prescribing doctor will need to write on the "Once only medication" section (front of the drug chart labeled with the patients URN and name).
"Trial medication, study number XXX: paracetamol 500mg ii
ibuprofen 200mg ii
one of codeine 30mg ii / oxycodone 5mg ii / thiamine 100mg ii"
The nurses & others involved in the trial are then legally able to sign out the trial packs and/or administer the medication to the patient from this drug order.

Drug packs will be pre-packaged in the hospital pharmacy and numbered sequentially. Treatment arms will be randomised in blocks of 18 packs. Neither the Study recruitment officer nor the patient will know which drugs have been administered.

To ensure this style of prescribing is adhered to & uniform across sites, we will purchase a stamp with the template for the medication order on it. The SRO or ED nurse will obtain the labeled study drug container from the drug safe and the identically numbered Study Kit from the drug room. The container will be labelled 'study drug'. The container will be an opaque plastic container and the contents cannot be seen from the outside.

The SRO will complete the initial sections of the Case Report Form (CRF) and obtain the first (Time 0) VAS rating.

The patient will be given the study medication and a cup of water and will be asked to take the study medications without looking at the tablets and out of view of the SRO. The SRO will ensure the obtaining of the follow up VAS ratings at Time 0+15min, 0+30min, 0+45min, 0+60 min and 0+90min. The need for additional analgesia (‘rescue medication’) will be assessed at each time point. To assess the need for rescue analgesia, patients will be asked if their pain is much better, a little better, much the same, a little worse, or much worse, and their answer will be documented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2010
Actual
1/10/2010
Date of last participant enrolment
Anticipated
31/10/2013
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2965 0
3186
Recruitment postcode(s) [2] 2966 0
3175

Funding & Sponsors
Funding source category [1] 257096 0
Hospital
Name [1] 257096 0
Southern Health Emergency Research Group
Country [1] 257096 0
Australia
Primary sponsor type
Hospital
Name
Southern Health Emergency Research Group
Address
Dept of Emergency Medicine
Monash Medical Centre
Clayton Rd
Clayton, 3168, Victoria
Country
Australia
Secondary sponsor category [1] 256353 0
None
Name [1] 256353 0
Address [1] 256353 0
Country [1] 256353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259129 0
Southern Health Human Research and Ethics Committee
Ethics committee address [1] 259129 0
Ethics committee country [1] 259129 0
Australia
Date submitted for ethics approval [1] 259129 0
15/05/2010
Approval date [1] 259129 0
Ethics approval number [1] 259129 0

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

Contacts
Principal investigator
Name 31253 0
Dr Alastair Meyer
Address 31253 0
Department of Emergency Medicine Casey Hospital 52 Kangan Drive Berwick, 3806, Victoria
Country 31253 0
Australia
Phone 31253 0
+61 3 8768 1200
Fax 31253 0
Email 31253 0
[email protected]
Contact person for public queries
Name 14500 0
Dr Alastair Meyer
Address 14500 0
Department of Emergency Medicine
Casey Hospital
52 Kangan Drive
Berwick, 3806, Victoria
Country 14500 0
Australia
Phone 14500 0
+61 3 8768 1200
Fax 14500 0
Email 14500 0
[email protected]
Contact person for scientific queries
Name 5428 0
Andis Graudins
Address 5428 0
Department of Emergency Medicine
Monash Medical Centre
Clayton Rd
Clayton, 3168, Victoria
Country 5428 0
Australia
Phone 5428 0
+61 3 9594 3195
Fax 5428 0
Email 5428 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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of paracetamol and ibuprofen with or without codeine or oxycodone as initial analgesia for adults with moderate pain from limb injury.2016https://dx.doi.org/10.1111/1742-6723.12672
N.B. These documents automatically identified may not have been verified by the study sponsor.