CompletedPhase 4ACTRN12612000795897

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.


Sponsor

Southern Health

Enrollment

80 participants

Start Date

Nov 1, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 13 Yearss

Inclusion Criteria3

  • 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.

Exclusion Criteria9

  • 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.

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Interventions

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

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


Locations(1)

Australia

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ACTRN12612000795897