ACTRN12612000795897
Completed
Phase 4
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.
Southern Health0 sites80 target enrollmentJuly 27, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- analgesic effectiveness
- Sponsor
- Southern Health
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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