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Trial registered on ANZCTR


Registration number
ACTRN12615000978561
Ethics application status
Approved
Date submitted
18/08/2015
Date registered
18/09/2015
Date last updated
28/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Supplementing Pain management in the emergency department – Conventional treatment versus Intravenous Adjunctive Low dose Ketamine: A single blind randomised control trial of ketamine versus opioids for trauma patients with moderate to severe pain
Scientific title
In trauma patients with moderate to severe pain, will treatment with low dose Ketamine as an analgesic adjunct with opiates compared to conventional treatment of opiate only improve pain outcomes?
Secondary ID [1] 285874 0
nil
Universal Trial Number (UTN)
Trial acronym
SPECIAL-K
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in trauma patients 293792 0
Condition category
Condition code
Injuries and Accidents 294096 294096 0 0
Other injuries and accidents
Anaesthesiology 296287 296287 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Initial dose intravenous ketamine at 0.2mg/kg over 5minutes.
If required, second dose ketamine within 15 minutes at 0.1mg/kg can be given. Morphine or morphine-equivalent opiates may be administered as breakthrough analgesia as boluses as determined by the treating physician.
Intervention code [1] 290855 0
Treatment: Drugs
Comparator / control treatment
Control Group: morphine or morphine-equivalent opiates given intravenously as a bolus at the discretion of the treating physician in relation to each individual participant. the standard of care is that the ED nurses will provide all opiate analgesia
Control group
Active

Outcomes
Primary outcome [1] 293883 0
pain scores: Visual analogue scale will be used to subjectively measure the participants pain.
Timepoint [1] 293883 0
60 minutes post trial initial administration of IV ketamine or opiate
Primary outcome [2] 293884 0
Analgesia requirements (total doses of adjunct and opiate medications).
A review of patient records in retrospective will provide the information of breakthrough analgesia required by all participants.
Timepoint [2] 293884 0
review of analgesia requirement from initial dose of either control or intervention medications through to 72 hours post initial dose.
Secondary outcome [1] 312082 0
Time to reduction of pain (measured on a visual analogue scale every 15 minutes for 60 minutes post intervention)
Timepoint [1] 312082 0
every 15min for 60 minutes
Secondary outcome [2] 312083 0
Patient satisfaction in the short and longer term with analgesia experience in the emergency department. this is a composite outcome.

the follow up questionnaire used to assess this has been specifically designed for this study.
Timepoint [2] 312083 0
from 24 to 72hours post intervention (within this time frame)
this variance is dependent on researcher availability
Secondary outcome [3] 312085 0
Reported adverse effects from study drugs such as:
hypo/hypertension
tachycardia
emergence phenomena
confusion
aggression
hyper-salivation
respiratory depression
nausea
vomiting
These will be objectively and subjectively monitored
Timepoint [3] 312085 0
15 minutely for 1hour post drug administration

adverse effects will be screened at the research follow up from 24 to 72 hours. Or if clinically indicated.

vital signs will be monitored dependent of each individual case, at minimum every 4 hours.
Secondary outcome [4] 312087 0
Impact on emergency department length of stay
This will be reviewed in retrospective through patient records
Timepoint [4] 312087 0
measure the patients ED length of stay, this can be achieved 2-3 days post patient hospital discharge
Secondary outcome [5] 312089 0
Incidence of persistent pain.
Participant questionnaire at 6 and 12 months, this questionnaire was specifically designed for the study.
Timepoint [5] 312089 0
6 and 12 months post intervention
Secondary outcome [6] 312090 0
At the 6 and 12 month follow-up, the participant will be asked to score (from 0-10) their satisfaction with their pain treatment in the ED. "0" being extremely dissatisfied, and "10" being extremely satisfied.
The participant will be asked if they have had a new diagnosis of post traumatic stress disorder or new psychological illness in the past 12 months since the research project.
Timepoint [6] 312090 0
6 and 12 months post medication intervention

Eligibility
Key inclusion criteria
all patients eligible will have to have presented to the emergency department
- Age greater than or equal to18years
- Major traumatic injuries that in the opinion of the treating emergency physician are likely to require high doses of opioid analgesia
- Have received at least one initial dose of morphine (0.1mg/kg), or morphine-equivalent opiate dosing (e.g. 10mcg/kg fentanyl), with ongoing pain scores of greater than or equal to 60mm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to ketamine or morphine
- Any state (e.g. intoxication) or medical history (e.g. mental health disorder) impairing accurate pain assessment or ability to provide informed consent
- Inability to communicate a pain score/complete follow-up questionnaire (intubation, sedation, altered level of consciousness, major head injury, significant anterograde amnesia, dementia, delirium, significant illness, poor English)
- Administration of ketamine prior to arrival in ED
- Administration of ketamine in the ED prior to patient recruitment (e.g. analgesia, procedural sedation)
- Clinical conditions in which the treating clinician is concerned that small increases in intracranial pressure may be deleterious
- Known or suspected raised intraocular pressure
- Current major psychiatric episode such as acute psychosis, mania or severe depression
- Pregnancy or breast feeding
- Known/suspected drug dependence

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)
Once eligibility is confirmed; clinicians will open a sequentially numbered (randomised number) opaque envelope to reveal the patients allocated treatment group. Treating clinicians will be required to enter patient details onto the envelope prior to opening and obtaining the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via an online application. both groups utilised with a catchment group of 100
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The visual analogue scale has been validated to detect clinically significant differences in pain scores in patients with acute traumatic pain at 13mm (95% CI 10-17mm). Therefore, to detect a clinically significant difference in mean pain scores of 15 mm on the VAS assuming a standard deviation of 25 mm, we would require 44 patients in each group with 80% power with a significance of 0.05%. To allow for attrition and withdrawal we aim to recruit a total of 100 patients to be split evenly between trial groups.
Data will be entered into an excel sheet which would be available for access only to the investigators. Data will be stored in a safe and secure location. Data will be analysed using SPSS 22.0. Continues variables will be tested for normality. Based on the outcome of the test parametric students T test or non-parametric Mann-Whitney test will be carried out to determine the differences in VAS scores. Categorical data will be analysed using the Chi-squared analysis. Bivariate analysis would be performed for determining the confounding factors contributing to ease of pain. A p value < 0.05 will be considered statistically significant.
All data will be analysed on an intention to treat basis. Patients who withdraw or are lost to follow up will be regarded as treatment failures for data analysis purposes and analysed with imputed data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3289 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 290456 0
Charities/Societies/Foundations
Name [1] 290456 0
Queensland Emergency Medicine Research Foundation
Country [1] 290456 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive, Douglas, QLD 4810
Country
Australia
Secondary sponsor category [1] 289158 0
None
Name [1] 289158 0
Address [1] 289158 0
Country [1] 289158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292128 0
Townsville Hospital and Health Service
Ethics committee address [1] 292128 0
The Townsville Hospital
IMB 48, PO Box 670,
Townsville QLD 4810
Ethics committee country [1] 292128 0
Australia
Date submitted for ethics approval [1] 292128 0
18/12/2014
Approval date [1] 292128 0
28/01/2015
Ethics approval number [1] 292128 0
EC00183

Summary
Brief summary
Pain is a common feature of major traumatic injuries. Little research has been done into the utilisation of low dose Ketamine for analgesia in the ED. Ketamine has the potential to be a highly effective method of analgesic management in haemodynamically unstable trauma patients who are unsuitable for large doses of opioid drugs but it is not utilised for this purpose due to a lack of supporting evidence and clinical concern about potential side effects. The clinical impact of this trial is in the development of an evidence base to support the use of Ketamine for analgesic purposes in the ED. Our hypothesis
is that low-dose Ketamine provides effective (statistically significant reduction in pain score), safe (low rates of emergence and adverse events) and tolerable (patient reported effects/willingness to use again) analgesia when used in sub-anaesthetic doses in patients with traumatic injuries. If proven this will have significant implications for the clinical care of patients and in pain management guidelines with traumatic injuries in the ED.
The proposed research design is a single blind randomised trial of low dose Ketamine in trauma patients. Participants will be randomised to receive a single dose of 'study drug' which will be either Ketamine (0.2mg/kg) or IV opiate (the dose determined by the clinician), this will be followed up by ongoing standard care for pain management (intravenous morphine or equivalent). Participants will record pain scores every 15 minutes for one hour post analgesic dose. Participants will also be clinically assessed every 15 minutes and have their vital signs and any side effects recorded. Additional 'rescue' analgesia will be available across both arms to ensure that patients are treated for ongoing pain.Rescue analgesia use will
also be recorded during the follow up period. Participants will be followed up 24-72hours after trial enrolment. Participants will have their vital signs recorded, will be assessed for adverse effects from the study drug and will be asked to complete a participant questionnaire. This short questionnaire will assess patient's satisfaction with pain management in the emergency department, their satisfaction with the 'study drug', any side effects experienced from the 'study drug' and their overall willingness to receive the 'study drug' again. Patients will be contacted at 6 and 12 months post enrolment to evaluate patient
satisfaction and long term safety of Ketamine as an analgesic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53638 0
Dr Luke Burman
Address 53638 0
PO Box 670
IMB 23
The Townsville Hospital
Townsville QLD 4810
Country 53638 0
Australia
Phone 53638 0
61 7 4433 1111
Fax 53638 0
Email 53638 0
[email protected]
Contact person for public queries
Name 53639 0
Luke Burman
Address 53639 0
PO Box 670
IMB 23
The Townsville Hospital
Townsville QLD 4810
Country 53639 0
Australia
Phone 53639 0
61 7 44331111
Fax 53639 0
Email 53639 0
[email protected]
Contact person for scientific queries
Name 53640 0
Luke Burman
Address 53640 0
PO Box 670
IMB 23
The Townsville Hospital
Townsville QLD 4810
Country 53640 0
Australia
Phone 53640 0
61 7 44331111
Fax 53640 0
Email 53640 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

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