Pain Reduction With Intranasal Medications for Extremity Injuries

Inadequate pain control, especially in the emergency department (ED), is a major public
health concern. Despite increased awareness, pain continues to be underdiagnosed and
undertreated, particularly in the pediatric population. Children often encounter long delays
in medication administration, possibly due to the time required to obtain intravenous access.
The intranasal administration route offers a more efficient alternative for faster and
noninvasive delivery of pain medication. This route is gaining popularity secondary to its
rapid onset of active, minimal discomfort and relative simplicity.

Opioids are the most commonly used class of analgesic pain medication for children presenting
in severe pain due to traumatic injuries. Despite their potential effectiveness, opioids have
several concerning adverse effects, particularly when administered prior to procedural
sedation in children. Administration of pre-procedural sedation opioids is associated with an
increased risk of serious adverse events (oxygen desaturation, apnea, and hypotension) as
well as the need for significant interventions, such as bag-mask ventilation, intubation, and
pharmacologic blood pressure support. In addition, due to genetic variations that may lead to
increased or diminished opioid sensitivity, ideal dosing to adequately control severe pain
yet avoid adverse medication-related side effects is difficult to ascertain. Many children in
severe pain do not receive opioids, receive doses that are below those recommended or
experience long delays in receiving opioids. The reasons for this are unclear, but the
investigators speculate that this may be due in part to fear of adverse effects of opioids,
provider inexperience with opioid use in children or fear of contributing to opioid tolerance
or abuse. For all of these reasons, providers often seek non-opioid alternatives for
pediatric patients with acute, severe pain.

Ketamine, in sub-dissociative doses administered by the intravenous or intranasal route, is
emerging as an alternative medication for the treatment of moderate to severe pain in
multiple settings. In adults, low dose ketamine is well tolerated and has been used
successfully as an adjuvant and an alternative to opioids to provide rapid pain relief in the
ED. As a dissociative anesthetic, ketamine is the most commonly used agent to facilitate
painful procedures in the pediatric emergency department. At lower doses, it has been used in
children to provide analgesia in a variety of acute and chronic pain settings, including
terminal diagnoses, sickle cell disease, perioperative pain, traumatic injuries, extensive
burns and conditions where opioids are contraindicated. Similar to adults, ketamine has been
used via the intranasal route to provide adequate analgesia and sedation in children in the
pre-hospital setting and in those undergoing procedures.

The objective of this study is to compare intranasal sub-dissociative ketamine with
intranasal fentanyl for treatment of acute pain associated with traumatic limb injuries in
children presenting to the ED and to document an objective respiratory side effect profile
utilizing noninvasive capnometry. If found to be an effective analgesic, intranasal ketamine
would be particularly useful in children who experience adverse effects with opioids, have
developed opioid tolerance as a result of chronic painful conditions, have poor opioid
sensitivity due to their genetic predisposition or in pediatric trauma patients with the
potential for hypotension. Additionally, for patients that require procedural sedation for
fracture reduction, avoiding opioids early in the emergency department visit may decrease
sedation recovery time and the risk of serious adverse events during sedation.

Inclusion Criteria:

- 8 years to 17 years (up to the 18th birthday)

- Presenting to emergency department with one or more extremity injuries

- Visual analog scale score 35 mm or greater

- Parent or legal guardian present and willing to provide written consent

Exclusion Criteria:

- Received narcotic pain medication prior to arrival

- Evidence of significant head, chest, abdomen, or spine injury

- Glasgow coma score less than 15 or unable to self report pain score

- Nasal trauma or aberrant nasal/airway anatomy

- Active epistaxis

- Allergy to ketamine, fentanyl or meperidine

- Non-English speaking parent and/or child

- History of psychosis

- Postmenarchal female without a urine or serum assay documenting the absence of
pregnancy

- Brought in my juvenile detention center or in police custody

- Pregnancy