TerminatedEarly Phase 1

Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Stopped: Initial results did not show benefit.

United States10 participantsStarted 2017-09-21

Plain-language summary

The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

Who can participate

Age range2 Years – 7 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus * Body weight of 20kg or less (actual, estimated, or measured) * NPO for four hours or more * Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure. Exclusion Criteria: * Discretion of parents * Discretion of provider * Body weight greater than 20kg (actual, estimated, or measured) * Starting Aldrete score \<9/10 * Known or suspected psychosis * Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure * Significant elevation in blood pressure * Known hypersensitivity to ketamine * Non-English or Spanish speaking

What they're measuring

Successful procedural sedation

Timeframe: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).

Trial details

NCT IDNCT03067974

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-22