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Trial registered on ANZCTR


Registration number
ACTRN12615001151527
Ethics application status
Approved
Date submitted
10/10/2015
Date registered
29/10/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
7/12/2018
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is ketamine a useful addition for the management of acute pain in patients where opiates alone have failed to provide adequate analgesia?
Scientific title
Double blind randomised controlled study to compare the usual practice of additional opiates with iv ketamine in unselected emergency patients complaining of moderate to severe pain despite already receiving opiate analgesia.
Secondary ID [1] 287443 0
Nil
Universal Trial Number (UTN)
Trial acronym
KAMA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult to control acute pain 296156 0
Condition category
Condition code
Emergency medicine 296440 296440 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effectiveness of intravenous ketamine in relieving moderate to severe acute pain in patients that have already received opiate analgesia by comparing verbal numeric rating scale pain scores at 30 and 60 minutes with controls. The ketamine will be given as 10mg aliquots every 5 minutes to a maximum of 40mg as guided by the patient's request for analgesia. The patient's pain scores and a record of whether any aliquots were given and at what times will be recorded using a standardised data collection tool.
Intervention code [1] 292812 0
Treatment: Drugs
Comparator / control treatment
Standard treatment: Intravenous morphine given as 2.5mg aliquots every 5 minutes to a maximum of 10mg as guided by the patient's request for analgesia.
Control group
Active

Outcomes
Primary outcome [1] 296061 0
The observed change in verbal numeric rating scale pain score.
Timepoint [1] 296061 0
30 and 60 minutes after receiving the first analgesia aliquot in the study
Secondary outcome [1] 317401 0
Observed change in vital signs i.e. blood pressure, heart rate, pulse oximetry and respiratory rate.
Timepoint [1] 317401 0
Time 0 to 90 minutes post initiation of study analgesia.
Secondary outcome [2] 317403 0
Change in conscious level as assessed using the Glasgow coma scale.
Timepoint [2] 317403 0
Time 0 to 90 minutes post initiation of study analgesia.
Secondary outcome [3] 317404 0
Incidence of adverse events. This will be recorded in a free text box in the data collection tool with the time that the event occurred. Common side effects can include: nystagmus, slurred speech, sleepiness and tear formation. This will be assessed and recorded with the observations of the attending physician.
Timepoint [3] 317404 0
Time 0 to 90 minutes post initiation of study analgesia.

Eligibility
Key inclusion criteria
Patients reporting acute onset of pain of any cause except cardiac origin but including cases where the cause is unknown. A verbal numeric rating scale pain score of greater than or equal to 5 after having received a total intravenous dose of 7.5mg morphine, 100mcg fentanyl or other equipotent opiate.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients whose primary language is other than English
Women who are pregnant
Patients aged <18 years
Patients with intellectual or mental impairment
A patient in whom we are unable to gain venous access
Patients with known chronic kidney disease stage 4 or above
Acute severe respiratory distress
Presenting with presumed cardiac diagnosis
A documented allergy to morphine or ketamine

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)
Eligible patients will be approached by their treating ED physician. Allocated treatment via sequentially numbered opaque sealed envelopes.
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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
26/10/2015
Date of last participant enrolment
Anticipated
Actual
4/06/2018
Date of last data collection
Anticipated
Actual
4/06/2018
Sample size
Target
65
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4329 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 10474 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 292015 0
Hospital
Name [1] 292015 0
Bundaberg Base Hospital
Country [1] 292015 0
Australia
Primary sponsor type
Hospital
Name
Bundaberg Base Hospital
Address
271 Bourbong St
Bundaberg
QLD 4670
Country
Australia
Secondary sponsor category [1] 290684 0
None
Name [1] 290684 0
Address [1] 290684 0
Country [1] 290684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293672 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [1] 293672 0
Level 2, E Block (PED Building)
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Ethics committee country [1] 293672 0
Australia
Date submitted for ethics approval [1] 293672 0
03/02/2015
Approval date [1] 293672 0
09/06/2015
Ethics approval number [1] 293672 0
HREC/15/QGC/39

Summary
Brief summary
Opioids have been successfully used as analgesics in the management of acute pain in the emergency department for many years. Unfortunately, in the setting of moderate to severe pain, the large doses required to relieve the pain are associated with adverse side effects. This can range from nausea and vomiting to respiratory depression. We believe that the addition of ketamine (a dissociative agent with analgesic properties) will help to alleviate moderate to severe pain that has not responded to traditional opioid dosing. The added benefit of the use of ketamine is that it has been shown to be a safe analgesic with a limited side effect profile at the doses required to provide adequate analgesia. The primary aim of the project will be to see if patients in the emergency department who have moderate to severe pain (defined as a pain score of >5/10) despite already receiving opiate analgesia can attain significantly better pain relief with the addition of ketamine rather than further doses of opiates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60186 0
Dr Thomas Papior
Address 60186 0
Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670
Country 60186 0
Australia
Phone 60186 0
+61 7 4150 2222
Fax 60186 0
Email 60186 0
thomas.papior@health.qld.gov.au
Contact person for public queries
Name 60187 0
Dr Thomas Papior
Address 60187 0
Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670
Country 60187 0
Australia
Phone 60187 0
+61 7 4150 2222
Fax 60187 0
Email 60187 0
thomas.papior@health.qld.gov.au
Contact person for scientific queries
Name 60188 0
Dr Thomas Papior
Address 60188 0
Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670
Country 60188 0
Australia
Phone 60188 0
+61 7 4150 2222
Fax 60188 0
Email 60188 0
thomas.papior@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data including full pain scores recorded.
When will data be available (start and end dates)?
After publication of results.
Available to whom?
This will be decided on a case-by-case basis
Available for what types of analyses?
Any purpose
How or where can data be obtained?
This will be subject to approval by the Principal Investigator and in conjunction with a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
665Study protocol    369282-(Uploaded-07-12-2018-08-45-47)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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