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Trial registered on ANZCTR


Registration number
ACTRN12612000795897
Ethics application status
Approved
Date submitted
25/07/2012
Date registered
27/07/2012
Date last updated
13/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial comparing the effectiveness of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries.
Scientific title
A randomized controlled trial comparing the effectiveness of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries.
Secondary ID [1] 280914 0
Nil
Universal Trial Number (UTN)
Trial acronym
PiCHForK Trial : Pain in Children: Fentanyl or Ketamine
Linked study record

Health condition
Health condition(s) or problem(s) studied:
analgesic effectiveness 286994 0
limb injury 286995 0
Condition category
Condition code
Anaesthesiology 287327 287327 0 0
Pain management
Injuries and Accidents 287328 287328 0 0
Other injuries and accidents
Musculoskeletal 287335 287335 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intranasal ketamine 1mg/kg as a single dose

plus

10mg/kg oral ibuprofen
Intervention code [1] 285349 0
Treatment: Drugs
Comparator / control treatment
intranasal fentanyl 1.5 micrograms/kg as a single dose

plus

10mg/kg oral ibuprofen
Control group
Active

Outcomes
Primary outcome [1] 287600 0
mean reduction in pain scores on visual analogue pain scale in children over 6 yo and Biere Faces pain scale (modified) in children under 6 yo
Timepoint [1] 287600 0
t=30 minutes
Secondary outcome [1] 298506 0
mean reduction in pain scores on visual analogue pain scale in children over 6 yo and Biere Faces pain scale (modified) in children under 6 yo
Timepoint [1] 298506 0
t=15 minutes and t=60 minutes
Secondary outcome [2] 298507 0
Percentage responding to each description of change in pain severity (a lot better, a little better, the same, a little worse, a lot worse)
Timepoint [2] 298507 0
t=15, 30 and 60 minutes
Secondary outcome [3] 298508 0
Percentage requiring any rescue-analgesia as additional dose of intranasal fentanyl or intravenous opioid at any time point during the hour-long observation period
Timepoint [3] 298508 0
t=15, 30 and 60 minutes
Secondary outcome [4] 298509 0
Percentage responding to each description of satisfaction with amount of analgesia experienced (satisfied, not satisfied, uncertain)
Timepoint [4] 298509 0
t=15, 30 and 60 minutes
Secondary outcome [5] 298510 0
Adverse event profile, specifically including:
i) Observed level of sedation using the University of Michigan Sedation Score (anxious/restless/both, cooperative/ orientated/ tranquil, respond to commands, brisk response to stimulus, sluggish response to stimulus, no response to stimulus).

ii) Self-reported or parent/guardian opinion on level of sedation

iii) Local adverse effects: presence of nasal irritation, bleeding or any local effects reported by the patient.

iv) Systemic adverse effects: changes in vital signs (tachycardia, hyper/hypotension), hallucinations (visual or other).

v) Suspected allergic reaction (incl type)

vi) Any other
Timepoint [5] 298510 0
t= 15, 30 and 60 minutes

Eligibility
Key inclusion criteria
Children aged three to 13 years and under 50kg body weight

Musculoskeletal injury to upper and/or lower limbs

Visual analogue pain score greater than or equal to 6/10 on the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) and patient would normally be considered for intranasal fentanyl administration.

Use of simple analgesia such as paracetamol or ibuprofen or inhalational methoxyflurane during ambulance transport are not exclusion criteria
Minimum age
3 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to gain informed consent from parent or guardian

Prior administration of parenteral or intranasal analgesics (morphine, fentanyl)

Prior administration of oral opioid analgesia (oxycodone, codeine)

Allergy to ketamine, fentanyl, or ibuprofen

Aberrant nasal anatomy

Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication.

Presence of multiple trauma or injuries.

Sustained a head injury with loss of consciousness.

Presence of cognitive impairment.

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)
In general, patients who are eligible for this study are triaged as Australasian Triage Scale (ATS) Category 2 because it is felt that they need analgesia within 10 minutes.

The ED triage nurse will notify the nominated Paediatric ED ‘Cat 2 doctor’ in the usual way. (Note: At the study ED, both the Cat 2 doctor and the ED Consultant In Charge (CIC) receive a pager notification of the arrival of a Category 2 patient (with whatever diagnosis), and so are usually aware of such patients prior to their reaching an ED cubicle.

The Cat 2 doctor will perform a rapid assessment of the patient in the usual way, which during the study period will include consideration of the study inclusion and exclusion criteria.

Obtaining a verbal numerical rating of pain severity is standard in this setting.

If the patient is eligible and the Cat 2 doctor or CIC believe that the time involved in patient recruitment will not have an adverse effect on either that patient’s management or the concurrent work of the ED, then either of these doctors or another delegate may broach study participation with the patient and their parent/guardian.

Initially, verbal consent for the administration of ketamine or fentanyl as a pain reliever will be sought from the parent/guardian by reading a pre-prepared information sheet describing the study.

This will be done to prevent delays to analgesia and the increased distress that are likely to occur in the recruitment of study subjects when a complete written PICF must be read and completed by the patient’s parent/guardian prior to the administration of analgesia. A similar approach to consent has been approved for our previous dose-finding studies of ketamine in children and adults.

Given that ketamine and fentanyl have both been shown to provide significant analgesia by the intranasal route in un-blinded studies we feel it is not unethical to gain initial verbal consent.

Oral ibuprofen (10mg/kg) will then be administered within the first 15 minutes of intranasal injection of the study drug in a weight-based dose appropriate for each child unless these drugs have already been given in the past 3 hours.

Written consent will be obtained once the printed PICF is given to the parent/guardian after analgesia has been ordered and administered, for the data collection, analysis and storage of pain scores, adverse events and other clinical data.

When the patient parent/guardian’s initial verbal consent is obtained, the attending doctor will calculate the appropriate dosage of Ketamine/Fentanyl from the chart attached to the data collection form and chart this for administration via the intranasal route.

The drug will be pre-prepared by the clinical trials pharmacist in pre-packaged blinded 2 ml syringes. The syringes will be block randomised at the time of preparation in the pharmacy department and then placed in the locked ED scheduled drug cupboard for use. The syringes will be taken from the cupboard in sequential order The volume to be administered will be calculated from the dosing table.

The syringe will contain 1.5 ml. This volume will be reduced to the appropriate total volume determined from the dosing table. Half of this final volume will be introduced into each nares by an atomizer device fitted to the end of the syringe. (NB. Staff are familiar with this equipment due to the common use of intranasal fentanyl for paediatric analgesia).

The patient (or if they are not able, their parent/guardian) will be asked to complete the baseline pain severity ratings (T0) and then the drug will be administered and signed for on the medication chart. As early as possible, the attending doctor will complete the baseline demographic information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block Randomisation undertaken by the clinical trials pharmacists at Monash Medical Centre
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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Compare change in VAS ratings at primary end point T30 and secondary endpoints T15, T60 to pre-treatment pain rating T0

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2012
Actual
1/11/2012
Date of last participant enrolment
Anticipated
30/11/2013
Actual
30/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285697 0
Charities/Societies/Foundations
Name [1] 285697 0
Jack Brockhoff Foundation
Country [1] 285697 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre
246 Clayton Rd,
Clayton, Vic, 3168
Country
Australia
Secondary sponsor category [1] 284526 0
University
Name [1] 284526 0
Monash University
Address [1] 284526 0
Southern Clinical School
Monash Medical Centre
246 Clayton Rd,
Clayton, Vic, 3168
Country [1] 284526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287695 0
Southern Health HREC-B
Ethics committee address [1] 287695 0
Ethics committee country [1] 287695 0
Australia
Date submitted for ethics approval [1] 287695 0
01/08/2012
Approval date [1] 287695 0
24/09/2012
Ethics approval number [1] 287695 0

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

Contacts
Principal investigator
Name 34486 0
Prof Andis Graudins
Address 34486 0
Dept of Emergency Medicine
135 Dandenong Hospital,
David Street,
Dandenong, Victoria, 3175
Country 34486 0
Australia
Phone 34486 0
+61 3 9554 9340
Fax 34486 0
Email 34486 0
[email protected]
Contact person for public queries
Name 17733 0
Professor Andis Graudins
Address 17733 0
Dept of Emergency Medicine
135 Dandenong Hospital,
David Street,
Dandenong, Victoria, 3175
Country 17733 0
Australia
Phone 17733 0
+61395943193
Fax 17733 0
Email 17733 0
[email protected]
Contact person for scientific queries
Name 8661 0
Professor Andis Graudins
Address 8661 0
Dept of Emergency Medicine
135 Dandenong Hospital,
David Street,
Dandenong, Victoria, 3175
Country 8661 0
Australia
Phone 8661 0
+61395943193
Fax 8661 0
Email 8661 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
EmbaseThe PICHFORK (Pain in Children Fentanyl or Ketamine) Trial: A randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries.2015https://dx.doi.org/10.1016/j.annemergmed.2014.09.024
N.B. These documents automatically identified may not have been verified by the study sponsor.