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Pain Reduction With Intranasal Medications for Extremity Injuries (PRIME)

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ClinicalTrials.gov Identifier: NCT02778880
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Traumatic Limb Injury Drug: Ketamine Drug: Fentanyl Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intranasal Sub-dissociative Dosing of Ketamine Compared to Intranasal Fentanyl for Treatment of Pain Associated With Acute Extremity Injuries in Children
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine
Ketamine 1.5 mg/kg intranasally for one dose
Drug: Ketamine
Other Name: Ketalar

Active Comparator: Fentanyl
Fentanyl 2 mcg/kg intranasally for one dose
Drug: Fentanyl



Primary Outcome Measures :
  1. Visual Analog Scale Pain Score [ Time Frame: 30 minutes ]
    Self reported pain score 30 minutes after study medication administration. Score is 0-100 mm (0 = no pain; 100 = worst pain imaginable)


Secondary Outcome Measures :
  1. University of Michigan Sedation Scale Score [ Time Frame: 15, 30 and 60 minutes ]
    Clinician reported sedation score 15, 30 and 60 minutes after study medication administration. Score is 0-4 (0 = awake and alert; 4 = unarousable)

  2. Adverse Events [ Time Frame: 15, 30 and 60 minutes ]
    Self and clinician reported adverse events 15, 30 and 60 minutes after study medication administration

  3. Additional opioid pain medication administration after study medication [ Time Frame: 15, 30 and 60 minutes ]
    Documentation of additional pain medication at 15, 30 and 60 minutes after study medication administration

  4. Visual Analog Scale Pain Score [ Time Frame: 15 and 60 minutes ]
    Self reported pain score 15 and 60 minutes after study medication administration. Score is 0-100 mm (0 = no pain; 100 = worst pain imaginable)

  5. Heart rate [ Time Frame: 15, 30 and 60 minutes ]
    Clinician obtained heart rate 15, 30 and 60 minutes after study medication administration.

  6. Respiratory rate [ Time Frame: 15, 30 and 60 minutes ]
    Clinician obtained respiratory rate 15, 30 and 60 minutes after study medication administration.

  7. Blood pressure [ Time Frame: 15, 30 and 60 minutes ]
    Clinician obtained blood pressure 15, 30 and 60 minutes after study medication administration.

  8. Oxygen saturation [ Time Frame: 15, 30 and 60 minutes ]
    Clinician obtained oxygen saturation 15, 30 and 60 minutes after study medication administration.

  9. Capnometry value [ Time Frame: 15, 30 and 60 minutes ]
    Clinician obtained capnometry value 15, 30 and 60 minutes after study medication administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778880


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Theresa M Frey, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Matthew R Mittiga, MD Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02778880     History of Changes
Other Study ID Numbers: CIN_PRIME_001
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Wounds and Injuries
Ketamine
Fentanyl
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia