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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000795897

Acronym

PiCHForK Trial : Pain in Children: Fentanyl or Ketamine

Enrollment

Registered

2012-07-27

Start date

2012-11-01

Completion date

2013-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Control of moderate to severe pain in children following limb injury is a significant challenge in the emergency department. Intranasal administration of fentanyl is commonly used to reduce pain in this group. Ketamine, is a commonly used drug for procedural sedation in the ED. It has recently been shown to also provide good analgesia in doses that do not produce sedation and can also be administered intranasally (IN). An observational dose-confirmation, first time in ED, study was recently undertaken in the paediatric emergency department of Monash Medical Centre revealing that IN ketamine provided pain relief comparable to that reported in observational studies where IN fentanyl was used in children with limb injuries. The observationa study suggests that IN ketamine may be an alterantive pain reliver in children with moderate to severe pain. However, neither ketamine or fentanyl have been assessed in a blinded fashion in treating pain in children. We aim to compare the effectiveness, side effects and satisfaction of IN ketamine to IN fentanyl in a randomised controlled double-blind fashion in children presenting to the ED with moderate to severe pain and limb injuries. The results of this study will help confirm the effectiveness of both pain relievers and ascertain whether IN ketamine can be used in place of fentanyl in this patient group.

Interventions

intranasal ketamine 1mg/kg as a single dose plus 10mg/kg oral ibuprofen

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

3 Years to 13 Years

Healthy volunteers

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

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.

Outcome results