NCT02635282

Brief Summary

The general objective of this study is to determine whether intranasal ketamine should be incorporated into formulary as an option to treat pain during minor procedures in the pediatric emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

December 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

December 9, 2015

Last Update Submit

March 23, 2017

Conditions

AbscessPain

Outcome Measures

Primary Outcomes (2)

  • Change in pain score measured utilizing the Faces Pain Scale-Revised

    The Faces Pain Scale-Revised will be used for children ages 3-7 years

    before medication administered and at 30 minutes after medication administration

  • Change in pain score measured utilizing the numeric pain rating scale

    The numeric pain rating scale will be used in children ages 8-17 years

    before medication administered and at 30 minutes after medication administration

Secondary Outcomes (2)

  • Vital sign measurements

    before medication administered and at 15 and 30 minutes after medication administration

  • Sedation score using the University of Michigan Sedation Scale

    before medication administered and at 15 and 30 minutes after medication administration

Study Arms (2)

IN fentanyl and midazolam

ACTIVE COMPARATOR

group of patients who are randomized to receive intranasal fentanyl and midazolam

Drug: intranasal fentanylDrug: intranasal midazolam

IN ketamine

EXPERIMENTAL

group of patients who are randomized to receive intranasal ketamine

Drug: intranasal ketamine

Interventions

intranasal ketamineDRUG
IN ketamine
intranasal fentanylDRUG
IN fentanyl and midazolam
intranasal midazolamDRUG
Also known as: Versed
IN fentanyl and midazolam

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of abscess with planned incision and drainage of a single abscess

You may not qualify if:

  • Fast Track patients
  • Patients who have received an opioid analgesic within the previous 4 hours of time of enrollment in study
  • Patients with parent or legal guardian not present to give informed consent for enrollment in study
  • Non-English speaking patients and/or parent
  • Patients with a contraindication for the administration of intranasal medication (nasal trauma, aberrant nasal anatomy)
  • Patients with ocular injuries
  • Patients with a known allergy to ketamine, fentanyl, and/or midazolam
  • Pregnant females
  • Patients with history of seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (4)

  • Bailey B, Gravel J, Daoust R. Reliability of the visual analog scale in children with acute pain in the emergency department. Pain. 2012 Apr;153(4):839-842. doi: 10.1016/j.pain.2012.01.006. Epub 2012 Feb 4.

    PMID: 22305630BACKGROUND

  • Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.

    PMID: 23365053RESULT

  • Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.

    PMID: 24127709RESULT

  • Del Pizzo J, Callahan JM. Intranasal medications in pediatric emergency medicine. Pediatr Emerg Care. 2014 Jul;30(7):496-501; quiz 502-4. doi: 10.1097/PEC.0000000000000171.

    PMID: 24987995RESULT

MeSH Terms

Conditions

AbscessPain

Interventions

Midazolam

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Pediatric Emergency Medicine Fellow

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 18, 2015

Study Start

August 1, 2016

Primary Completion

March 23, 2017

Study Completion

March 23, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)