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Completed

NCT Number: NCT02778880

Pain Reduction With Intranasal Medications for Extremity Injuries

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Other names: Ketalar

Fentanyl

Drug

Primary outcomes

  1. Difference From Baseline in Visual Analog Scale Pain Score

    Time frame: 30 minutes after study medication

    A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.

Secondary outcomes

  1. Difference From Baseline in Visual Analog Scale Pain Score

    Time frame: 15 minutes after study medication

    A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.

  2. Difference From Baseline in Visual Analog Scale Pain Score

    Time frame: 60 minutes after study medication

    A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.

  3. Highest Achieved University of Michigan Sedation Scale (UMSS) Score

    Time frame: 15, 30, and 60 minutes after study medication administration

    The University of Michigan Sedation Scale is a valid and reliable tool that allows for rapid assessment of the depth of sedation in children. It is a simple observational tool that assesses the level of alertness on a five-point scale. It has been validated in children and has shown to have significant inter-rater reliability. Score is 0-4 (0 = awake and alert; 1= minimally sedated; 2 = moderately sedated; 3 = deeply sedated; 4 = unarousable)

  4. Rescue Analgesia

    Time frame: Within the first 60 minutes after study medication

    Documentation of additional pain medication after study medication administration

  5. Heart Rate

    Time frame: 15 minutes after study medication

  6. Heart Rate

    Time frame: 30 minutes after study medication

  7. Heart Rate

    Time frame: 60 minutes after study medication

  8. Respiratory Rate

    Time frame: 15 minutes after study medication

  9. Respiratory Rate

    Time frame: 30 minutes after study medication

  10. Respiratory Rate

    Time frame: 60 minutes after study medication

  11. Systolic Blood Pressure

    Time frame: 15 minutes after study medication

  12. Systolic Blood Pressure

    Time frame: 30 minutes after study medication

  13. Systolic Blood Pressure

    Time frame: 60 minutes after study medication

  14. Diastolic Blood Pressure

    Time frame: 15 minutes after study medication

  15. Diastolic Blood Pressure

    Time frame: 30 minutes after study medication

  16. Diastolic Blood Pressure

    Time frame: 60 minutes after study medication

  17. Oxygen Saturation

    Time frame: 15 minutes after study medication

  18. Oxygen Saturation

    Time frame: 30 minutes after study medication

  19. Oxygen Saturation

    Time frame: 60 minutes after study medication

  20. Capnometry Value

    Time frame: 15 minutes after study medication

  21. Capnometry Value

    Time frame: 30 minutes after study medication

  22. Capnometry Value

    Time frame: 60 minutes after study medication

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study 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

Acronym: PRIME

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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