Pain Reduction With Intranasal Medications for Extremity Injuries
Condition: Pain; Traumatic Limb Injury
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine
      and intranasal fentanyl in children presenting to the Emergency Department with acute
      extremity injuries.
    

Detailed description: 
      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.
    

Intervention name(s): Ketamine; Fentanyl
Intervention type(s): Drug; Drug
Other intervention name(s): Ketalar
Intervention MeSH terms: Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment