IN Sub-Dissociative Ketamine vs IN Fentanyl

NCT02521415 | Completed Phase 2 Results DMC

• 1 other identifier: INK-2015
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fracture

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events

  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 significant adverse events. Side effects are common events experienced by patients receiving ketamine or fentanyl that do not change outcomes for the patient but may affect the patient experience. A significant adverse event (SAE) includes any adverse event that begins after the short form consent has been completed that causes a threat to life, limb or an organ system, causes prolongation of hospitalization, or requires new medical or surgical treatment to correct.

  60 minutes

Secondary Outcomes (1)

• Secondary Outcome: Total Dose of Opioid Pain Medication in Morphine Equivalents/kg/Hour

  participants will be followed during the emergency department length of stay, estimated to average 6 hours

Other Outcomes (2)

• Exploratory Outcome: Reduction in Age Appropriate Pain Scale Scores

  20 minutes

• Secondary Safety Outcome: Adverse Events Over 6 Hours

  6 hours

Study Arms (2)

ketamine

EXPERIMENTAL

ketamine (1mg/kg)

Drug: ketamine; Drug: ibuprofen or acetaminophen

fentanyl

ACTIVE COMPARATOR

fentanyl (1.5 micrograms/kg)

Drug: fentanyl; Drug: ibuprofen or acetaminophen

Interventions

ketamine DRUG

intranasal (IN) sub-dissociative ketamine (1mg/kg)

Also known as: intranasal pain medication

ketamine

fentanyl DRUG

Intranasal (IN) fentanyl (1.5 micrograms/kg)

Also known as: intranasal pain medication

fentanyl

ibuprofen or acetaminophen DRUG

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

fentanyl; ketamine

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• single suspected, isolated extremity fracture that requires analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Carolinas Trauma Network Research Group: collaborator
• Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC: collaborator

Study Sites (1)

Carolinas Medical Center Main - Levine Children's Hospital Emergency Department

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

• Reynolds SL, Studnek JR, Bryant K, VanderHave K, Grossman E, Moore CG, Young J, Hogg M, Runyon MS. Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department. BMJ Open. 2016 Sep 8;6(9):e012190. doi: 10.1136/bmjopen-2016-012190.

  PMID: 27609854 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Ketamine; Fentanyl; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Stacy Reynolds
• Organization: Carolinas Medical Center

stacy.reynolds@carolinashealthcare.org

704-355-3181

Study Officials

• Stacy Reynolds, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 13, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2018-02

Locations

US (1)