ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Emergency medicine

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]

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]

The observed change in verbal numeric rating scale pain score.

Timepoint [1]

30 and 60 minutes after receiving the first analgesia aliquot in the study

Secondary outcome [1]

Observed change in vital signs i.e. blood pressure, heart rate, pulse oximetry and respiratory rate.

Timepoint [1]

Time 0 to 90 minutes post initiation of study analgesia.

Secondary outcome [2]

Change in conscious level as assessed using the Glasgow coma scale.

Timepoint [2]

Time 0 to 90 minutes post initiation of study analgesia.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Bundaberg Hospital - Bundaberg

Recruitment postcode(s) [1]

4670 - Bundaberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Bundaberg Base Hospital

Address [1]

271 Bourbong St
Bundaberg
QLD 4670

Country [1]

Australia

Primary sponsor type

Hospital

Name

Bundaberg Base Hospital

Address

271 Bourbong St
Bundaberg
QLD 4670

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Health Service District Human Research Ethics Committee

Ethics committee address [1]

Level 2, E Block (PED Building)
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/02/2015

Approval date [1]

09/06/2015

Ethics approval number [1]

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

Dr Thomas Papior

Address

Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670

Country

Australia

Phone

+61 7 4150 2222

Fax

thomas.papior@health.qld.gov.au

Contact person for public queries

Name

Thomas Papior

Address

Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670

Country

Australia

Phone

+61 7 4150 2222

Fax

thomas.papior@health.qld.gov.au

Contact person for scientific queries

Name

Thomas Papior

Address

Dept of Emergency Medicine
Bundaberg Base Hospital
271 Bourbong St
Bundaberg
QLD 4670

Country

Australia

Phone

+61 7 4150 2222

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
665	Study protocol					369282-(Uploaded-07-12-2018-08-45-47)-Study-related document.doc

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.

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