Sedation
Conditions
Keywords
Procedural Sedation
Brief summary
The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.
Interventions
DRUGKetamine
Intranasal Ketamine (100 mg/mL)
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* pediatric patients age 2 to 17 years old * have a laceration of 4 cm on the face or 7 cm on the remainder of the body * Require procedural sedation to repair the laceration
Exclusion criteria
* Patients with abnormal nasal physiology which would not allow for adequate medication delivery * Unable to have a guardian present to consent on their behalf * Allergy to ketamine * Significant cardiac history (myocardial ischemia, heart failure, arrhythmias) * Presenting with a head injury associated with possible intracranial hypertension * Pregnancy * Lacerations that require repair from a consult service
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Sedation | Every 60 seconds through study completion | Minutes it takes until the patient is cooperative enough for the procedure |
Countries
United States
Participant flow
Recruitment details
6 months
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Ketamine | 2 |
| Intramuscular Ketamine | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Intranasal Ketamine | Total | Intramuscular Ketamine |
|---|---|---|---|
| Age, Continuous | 3 years STANDARD_DEVIATION 1 | 3 years STANDARD_DEVIATION 0 | 3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Onset of Sedation
Minutes it takes until the patient is cooperative enough for the procedure
Time frame: Every 60 seconds through study completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intranasal Ketamine | Onset of Sedation | NA Participants |
| Intramuscular Ketamine | Onset of Sedation | NA Participants |