NCT02778880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

April 19, 2016

Results QC Date

July 28, 2020

Last Update Submit

August 18, 2020

Conditions

PainTraumatic Limb Injury

Outcome Measures

Primary Outcomes (1)

  • Difference From Baseline in Visual Analog Scale Pain Score

    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.

    30 minutes after study medication

Secondary Outcomes (22)

  • Difference From Baseline in Visual Analog Scale Pain Score

    15 minutes after study medication

  • Difference From Baseline in Visual Analog Scale Pain Score

    60 minutes after study medication

  • Highest Achieved University of Michigan Sedation Scale (UMSS) Score

    15, 30, and 60 minutes after study medication administration

  • Rescue Analgesia

    Within the first 60 minutes after study medication

  • Heart Rate

    15 minutes after study medication

  • +17 more secondary outcomes

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine 1.5 mg/kg intranasally for one dose

Drug: Ketamine

Fentanyl

ACTIVE COMPARATOR

Fentanyl 2 mcg/kg intranasally for one dose

Drug: Fentanyl

Interventions

KetamineDRUG
Also known as: Ketalar
Ketamine
FentanylDRUG
Fentanyl

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Frey TM, Florin TA, Caruso M, Zhang N, Zhang Y, Mittiga MR. Effect of Intranasal Ketamine vs Fentanyl on Pain Reduction for Extremity Injuries in Children: The PRIME Randomized Clinical Trial. JAMA Pediatr. 2019 Feb 1;173(2):140-146. doi: 10.1001/jamapediatrics.2018.4582.

    PMID: 30592476DERIVED

MeSH Terms

Conditions

Pain

Interventions

KetamineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Convenience sample; 4 patients withdrew before medication given; Conservative choice of non-inferiority margin; Interventions like splinting or child life presence were not assessed; Rescue analgesia was at the discretion of the primary provider

Results Point of Contact

Title
Theresa Frey, MD
Organization
Cincinnati Children's Hospital Medical Center
theresa.frey@cchmc.org
513-636-7966

Study Officials

  • Theresa M Frey, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Matthew R Mittiga, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 20, 2016

Study Start

March 31, 2016

Primary Completion

February 22, 2017

Study Completion

March 21, 2017

Last Updated

September 1, 2020

Results First Posted

September 1, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)