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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03067974
Other study ID # 1705414419
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date September 21, 2017
Est. completion date January 22, 2019

Study information

Verified date January 2019
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date January 22, 2019
Est. primary completion date January 22, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine Hcl 100Mg/Ml Inj
10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation

Locations

Country Name City State
United States Banner Univsersity Medical Center Tucson Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful procedural sedation Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication. 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).
See also
  Status Clinical Trial Phase
Completed NCT04701008 - Efficacy of Ketamine in Post Anesthesia Recovery Room
Recruiting NCT04490031 - Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 4
Completed NCT00486902 - Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients? N/A
Completed NCT03979105 - Cardiovascular Safety After Continuous Ketamine Infusion
Completed NCT03525912 - Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions N/A