Intranasal versus intravenous ketamine for procedural sedation in children: a randomized controlled non-inferiority multicenter trial (INK Trial)

 
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Overview

Status:
ClinicalTrials.gov Identifier:
Principal Investigator:
Project Manager:

Objectives

Primary Objective:

In children aged 7 to 17 years with a distal forearm fracture or dislocation of the shoulder, elbow, patella, or digit requiring closed reduction, our objective is to determine if intranasal (IN) ketamine is non-inferior to intravenous (IV) ketamine with respect to the proportion of participants that achieve adequate sedation for the duration of the closed reduction procedure. Adequate sedation is defined as a (i) Dartmouth Operative Conditions Scale (DOCS) [9] score between -2 and +2 for the duration of the closed reduction AND, (ii) No additional IV ketamine is given during closed reduction for the purpose of sedation,  AND (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction.

Secondary Objectives:

1.  To characterize the sedation characteristics of IN ketamine with respect to onset, depth, duration of sedation, length of stay, need for additional sedation, nasal irritation, satisfaction with sedation, and adverse effects including unpleasant recovery reactions

2.  To concurrently validate the Pediatric Sedation State Scale (PSSS)[10] with the DOCS

3.  To characterize patient-centered outcomes related to IV insertion such as pain, number attempts, and time to successful placement of an IV

inclusion criteria

TBD

exclusion criteria

TBA