The PICHFORK (Pain InCHildren Fentanyl OR Ketamine) trial comparing the efficacy of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries: study protocol for a randomized controlled trial

Table 1 Inclusion and exclusion criteria of the ‘PICHFORK’ trial

Inclusion criteria	Exclusion criteria
Children aged three to thirteen years and up to 50 kg body mass	Inability to gain informed consent from parent or guardian
Children with an isolated musculoskeletal injury of the limb	Treatment with serotonergic antidepressants, prior administration of parenteral or IN analgesics or opioid analgesia, and opioid antagonist use
Reported pain severity greater than or equal to 6 in the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) at triage	Children with allergy to ketamine, fentanyl, or ibuprofen
Children that would normally be considered for IN fentanyl administration for analgesia at Monash Health EDs.	Aberrant nasal anatomy, acute or chronic nasal problems or nasal trauma that may preclude adequate intranasal delivery
	Presence of multiple trauma and/or head injury with loss of consciousness, and/or cognitive impairment.

Note: Use of simple analgesia such as paracetamol or ibuprofen or inhalational methoxyflurance within four hours prior to ED arrival does not exclude participation. ED emergency department, IN intranasal.

ISSN: 1745-6215