Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Ketamine

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.

Intervention / Treatment

Intranasal ketamine (DRUG)

N/A

Condition or Disease

Laceration

Phase

Phase 2

Study Design

Study type:	INTERVENTIONAL
Status:	Completed
Study results:	No Results Available
Age:	1 Year to 7 Years
Enrollment:	45 (ESTIMATED)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Treatment
Masking

Clinical Trial Dates

Start date:	May 01, 2007
Primary Completion:	Aug 31, 2020
Completion Date:	Feb 01, 2010	ACTUAL
Study First Posted:	Mar 23, 2007	ESTIMATED
Results First Posted:	Aug 31, 2020
Last Updated:	Jul 21, 2010

Sponsors / Collaborators

Lead Sponsor: Rhode Island Hospital

Responsible Party: N/A

No responsible party listed

Location

Providence, Rhode Island, USA

Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

Eligibility Criteria

Sex:	All
Minimum Age:	1
Maximum Age:	7
Age Groups:	Child
Healthy Volunteers:	Yes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary Outcomes

Efficacy of sedation (OSBDR) 30 minutes
Time to onset of sedation (Ramsay 6-point Sedation Scale) 30 minutes

Secondary Outcomes

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
Administration of supplemental sedative medication During time required for procedure
Prolonged sedation (i.e. > 1 hour) Until time of discharge from emergency department

More Details

NCT Number:	NCT00451724
Other IDs:	0014-07
Study URL:	https://clinicaltrials.gov/study/NCT00451724

Last updated: Sep 29, 2023