NCT00451724

Brief Summary

The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 22, 2010

Status Verified

July 1, 2010

First QC Date

March 21, 2007

Last Update Submit

July 21, 2010

Conditions

Laceration

Keywords

ProspectiveRandomizedDouble blindedSedationKetamineIntranasal

Outcome Measures

Primary Outcomes (2)

  • Efficacy of sedation (OSBDR)

    30 minutes

  • Time to onset of sedation (Ramsay 6-point Sedation Scale)

    30 minutes

Secondary Outcomes (7)

  • Duration of sedation

    Up to 1 hour

  • Primary caregiver satisfaction

    24 hours

  • Physician satisfaction

    Duration of procedure

  • Ketamine bioavailability

    1 hour

  • Abnormalities in cardiopulmonary function

    Until time of discharge

  • +2 more secondary outcomes

Interventions

Intranasal ketamineDRUG

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 1 to 7 years old
  • Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours.
  • Physician feels that intravenous sedation is required to perform the laceration repair

You may not qualify if:

  • Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure
  • Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV
  • Known diagnoses of hyperthyroidism or porphyria
  • Glaucoma or penetrating eye injury
  • Hypertension
  • Any contraindication, including drug allergy, to study medications
  • Severe trauma with other injuries requiring operative intervention
  • Abnormal neurological exam in a previously normal child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • James G Linakis, PhD, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

May 1, 2007

Study Completion

February 1, 2010

Last Updated

July 22, 2010

Record last verified: 2010-07

Locations

US(1)