Pediatric Ketamine Study for Pain Management
Pediatric Ketamine Study for Pain Management
Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for
 the treatment of moderate to severe pain in pediatric patients in the emergency department.
Intranasal (IN) delivery of analgesic agents provides rapid and convenient drug
 administration without the need for needles. In children, the placement of an intravenous
 line often increases anxiety and pain, requires nursing time, and can be very difficult to
 achieve, so the IN route is particularly advantageous. IN delivery of fentanyl has become
 increasingly more common in pain management for children in many settings, including
 pre-hospital and emergency department (ED) settings. Over the past decade, many studies have
 demonstrated that intranasal fentanyl is as effective as intravenous morphine to treat acute
 moderate to severe pain. Intranasal fentanyl has become standard of care in some pediatric
 EDs with the advantage of avoiding intravenous line placement. However, adverse effects
 attributed to IN fentanyl are similar to those of other opioid analgesics: hypotension,
 sedation, and occasionally respiratory depression. Ketamine is a noncompetitive N-methyl
 D-aspartate (NMDA) receptor antagonist that blocks the release of the excitatory
 neurotransmitter glutamate and provides anesthesia, amnesia, and analgesia by decreasing
 central sensitization and "wind-up" phenomenon. Due to its high lipid solubility, ketamine
 rapidly crosses the blood-brain barrier, provides rapid onset of action (peak concentration
 at 1 minute after intravenous push) and rapid recovery to baseline (duration of action 5-15
 minutes after intravenous push). At sub-dissociative doses, either used as an adjunct to
 opioid analgesics or as a solo agent, ketamine provides effective analgesia while preserving
 airway patency, ventilation, and cardiovascular stability.

 Ketamine has been less studied for pain management, however it has been safely used via
 different routes of administration in children. Studies dating back to 1990's use ketamine at
 doses as high as 6 mg/kg intranasally in children for pre-medication prior to surgery or for
 sedation with little or no reported adverse effects. A hospital in Australia is currently
 conducting a clinical trial comparing IN fentanyl 1.5 ug/kg to IN ketamine 1mg/kg for the
 treatment of pain caused by isolated musculoskeletal injury. The intention of our study is
 similar to this, however the investigators will not limit the patients to those with only
 musculoskeletal pain and a more simplified pain scale will be used.

 To assess pain, the investigators will use the standard pain scale that is currently used in
 our Pediatric ED in order to minimize the need to re-train any of our staff with a different
 pain scale. The scale incorporates the Numerical rating scale (0-10 scale; NRS) and the
 Wong-Baker faces pain scale (6 faces corresponding to 0,2,4,6,8,10; WBS). While prior studies
 have used different pain scales, primarily the visual analog scale (VAS), the scales that the
 investigator currently use have been validated in children in 2009.
Inclusion Criteria:

 -  Children aged 3-17,

 -  weighing less than 50kg

 -  present to the pediatric ED with moderate-severe acute pain (defined as pain greater
 than or equal to 6/10).

 -  Treating physician determines the patient to require opioid analgesia.

 Exclusion Criteria:

 -  Children with facial trauma or any abnormal nasal anatomy;

 -  developmentally delayed children;

 -  children with head trauma/increased intracranial pressure (ICP);

 -  children with known allergy to fentanyl or ketamine;

 -  children who are unable to provide pain scale assessment;

 -  children with chronic pain of greater than 4 weeks;

 -  Pregnant females;

 -  and children with a Glasgow Coma Scale (GCS)<15.