ACTRN12612000012875
Completed
Phase 4
A dose-finding study assessing the effectiveness of sub-dissociative doses of intranasal ketamine in the treatment of moderate to severe acute pain in the emergency department in children. Part One of a two-part study protocol.
Southern Health0 sites60 target enrollmentJanuary 4, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- acute pain
- Sponsor
- Southern Health
- Enrollment
- 60
- 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 analog 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
- •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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