NCT02839928

Brief Summary

Nasal Ketamine has previously been tested in children for deep sedation or preoperative anxiolysis. The investigators intend to test the efficacy of low dose nasal Ketamine in children undergoing minor procedures in the emergency department.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable pain

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

July 13, 2016

Last Update Submit

July 18, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score (VAS)

    The investigators will record the visual analog scale pain score as reported by patients and caregivers both before and after the administration of intranasal ketamine

    Up to 24 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

The experimental arm consists of children given intranasal Ketamine 1 mg/kg, once

Drug: Intranasal ketamineDevice: Intranasal atomizerDrug: EMLA

Interventions

Intranasal ketamineDRUG

The experimental arm consists of an single intranasal administration of Ketamine (Ketalar).

Also known as: Ketalar
Treatment
Intranasal atomizerDEVICE

Ketamine will be applied to each nare via intranasal atomizer

Also known as: LMA MAD intranasal atomizer
Treatment
EMLADRUG
Also known as: EMLA cream, a topical analgesic, will be applied prior to the procedure
Treatment

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children age 4-12 years old presenting to the pediatric ED
  • Children determined by the treating physician to require either venipuncture or IV placement
  • Children determined by the treating physician to show resistance to the procedure without pre-medication

You may not qualify if:

  • ASA 3 or higher
  • Weight below 15 kg or above 50 kg
  • Hypoxia below 95% on presentation or noted to be tachypneic for age or dyspneic.
  • Judged by staff to need an urgent procedure that cannot be delayed (i.e. Nursing triage levels 1-2)
  • An existing source of pain that results in a VAS greater than 3 at triage (i.e. Headache, fracture)
  • More than four prior ED visits in the last four months
  • Developmentally delayed and unable to reliably rate pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

KetamineLidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsLidocaineAcetanilidesAnilidesAmidesPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Eric Scheier, MD

    Physician, pediatric emergency department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Scheier

CONTACT

4103586230eric.scheier@gmail.com

Eric Scheier

CONTACT

011972527276804eric.scheier@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 21, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share