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IN Sub-Dissociative Ketamine vs IN Fentanyl

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ClinicalTrials.gov Identifier: NCT02521415
Recruitment Status : Unknown
Verified September 2016 by Stacy Reynolds, Atrium Health.
Recruitment status was:  Recruiting
First Posted : August 13, 2015
Last Update Posted : October 3, 2016
Sponsor:
Collaborators:
Carolinas Trauma Network Research Group
Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC
Information provided by (Responsible Party):
Stacy Reynolds, Atrium Health

Brief Summary:

This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.


Condition or disease Intervention/treatment Phase
Bone Fracture Drug: ketamine Drug: fentanyl Drug: ibuprofen or acetaminophen Phase 2

Detailed Description:

Intranasal medications are commonly used in place of parenteral opioids in children. IN fentanyl is the most commonly used intranasal analgesic medication in the pediatric population with demonstrated safety and efficacy comparable to IV fentanyl and IV morphine. IN ketamine, at sub-dissociative doses, offers similar safety and efficacy to IN fentanyl and the additional advantage of potentially reducing the total use of opioid agents during the emergency department visit. Ketamine is easily stored and has a wide therapeutic window with an extremely low risk of cardiorespiratory complications. This study will compare the safety and efficacy of IN ketamine to IN fentanyl in children with suspected, isolated extremity fractures in the pediatric emergency department.

The primary aim of the study is to examine the feasibility of future protocol expansion. The investigators will conclude that additional studies are NOT feasible if the observed rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related SAEs. The primary aim of the study will compare the frequency of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department. The exploratory aim of the study will compare the efficacy of intranasal ketamine to intranasal fentanyl as measured by a reduction in age appropriate pain scale scores over 2-hours. The secondary aim of the study will compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected, isolated extremity fractures after randomization and treatment with IN ketamine or IN fentanyl.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

All participants will be premedicated with acetaminophen or ibuprofen and baseline data, including pain level, will be collected. The trial consists of two treatment arms. (IN ketamine 1 mg/kg or IN fentanyl 1.5 mcg/kg). Randomization will follow a 1:1 ratio, with approximately 40 per group. Randomization will be stratified by ages 3-10 and 11-17. The participants will be assessed by a research coordinator for adverse events every 5 minutes using an adverse events checklist for the first fifteen minutes post study medication administration and every 30 minutes for the first two hours after drug administration. The vital signs and pain scale assessment will be repeated every 10 minutes for the first 30 minutes and then every 30 minutes for the first two hours after drug administration. A final assessment will be made 6 hours after the last dose of study drug or at discharge from the ED to assess for late side effects or adverse events. Study medication may be repeated times one at a reduced dose after 20 minutes when the full effects of the first dose are known. The decision to administer additional study medication (0.5 mg/kg ketamine or 0.75 mcg/kg fentanyl ) will at be at the discretion of the treating physician. Should a second dose of study medication be required, a new schedule of patient assessments will commence following the same schedule as for the first dose. Participant assessments will continue until the 2 hour endpoint is reached from the time of the last drug administration, with a final assessment at 6 hours after the last dose of study drug or at discharge from the ED to assess for late side effects or adverse events.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children With Suspected, Isolated Extremity Fractures in the Pediatric Emergency Department
Study Start Date : December 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: ketamine
ketamine (1mg/kg)
Drug: ketamine
intranasal (IN) sub-dissociative ketamine (1mg/kg)
Other Name: intranasal pain medication

Drug: ibuprofen or acetaminophen
10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention

Active Comparator: fentanyl
fentanyl (1.5 micrograms/kg)
Drug: fentanyl
Intranasal (IN) fentanyl (1.5 micrograms/kg)
Other Name: intranasal pain medication

Drug: ibuprofen or acetaminophen
10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention




Primary Outcome Measures :
  1. Primary outcome: proportion of participants with minor side effects and significant adverse events [ Time Frame: 60 minutes ]
    We will conclude that such a study is NOT feasible if we observe a rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related SAEs.


Secondary Outcome Measures :
  1. Secondary outcome: total dose of opioid pain medication in morphine equivalents/kg/hour [ Time Frame: participants will be followed during the emergency department length of stay, estimated to average 6 hours ]
    Compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected forearm fractures after randomization and treatment with IN ketamine or IN fentanyl.


Other Outcome Measures:
  1. Exploratory Outcome: reduction in age appropriate pain scale scores [ Time Frame: 20 minutes ]
    difference in the reduction of the pain scale scores at 20 minutes.

  2. Secondary safety outcome: proportion of patients with types of adverse events [ Time Frame: 6 hours ]
    Compare the frequency of types of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single suspected, isolated extremity fracture that requires analgesia

Exclusion Criteria:

  • GCS < 15 at ED presentation,
  • reported allergy or adverse reaction to ketamine or fentanyl,
  • pregnancy,
  • intoxication,
  • hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than 11 years of age)
  • weight > 70 kg
  • patients receiving opioid analgesia administered prior to arrival
  • multiply injured patients (injuries to multiple extremities)
  • aberrant nasal anatomy that precludes IN medications

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): NCT02521415


Contacts
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Contact: Melanie M Hogg, BS 704-355-4288 melanie.hogg@carolinashealthcare.org

Locations
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United States, North Carolina
Carolinas Medical Center Main - Levine Children's Hospital Emergency Department Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Melanie M Hogg, BS    704-355-4288    melanie.hogg@carolinashealthcare.org   
Principal Investigator: Stacy Reynolds, MD         
Sponsors and Collaborators
Atrium Health
Carolinas Trauma Network Research Group
Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC
Investigators
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Principal Investigator: Stacy Reynolds, MD Carolinas Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stacy Reynolds, Pediatric Emergency Medicine Clinical Faculty, Atrium Health
ClinicalTrials.gov Identifier: NCT02521415     History of Changes
Other Study ID Numbers: INK-2015
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Acetaminophen
Ibuprofen
Fentanyl
Ketamine
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
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors