Ketamine Compared to Propofol for Pediatric GI Endoscopy

Endoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614159
• Other study ID #: 5545UMU
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: June 30, 2009
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Elective outpatient endoscopy for children can be safely performed under general anesthesia with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over general anesthesia with volatile agents because they do not require intubation. The goal of both infusions is to have the patient breath spontaneously without reacting to the endoscopy which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the procedure and increase overall OR time. Propofol also carries the added risk of causing apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's profile makes it a superior drug to Propofol for elective outpatient endoscopy because of reduced profound intra-operative interruptions and faster recovery time. We plan a study of pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The patients will be randomized to receiving either a Ketamine or Propofol infusion, and the intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic Care Unit (PACU) time to recovery will be monitored and recorded by a third party.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Age 1-10

• Endoscopy with sedation scheduled

Exclusion Criteria:

• A history of chronic respiratory disease

• Upper respiratory infection

• Developmental delays

• Dysrhythmias

• Increased intercranial pressure

• Any sedatives or narcotics up to 6 weeks prior to procedure.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endoscopy

Intervention

Drug:
• Ketamine
Weight based dosage for Peds subjects, used for duration of the endoscopy.
• Propofol
Weight based dosage for Peds subjects, used for duration of the endoscopy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University