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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587665
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy


Condition Intervention
Pain
 Drug: ketamine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study of Low Dose Ketamine as an Adjunct to Fentanyl in Pediatric Patients Following Outpatient Tonsillectomy and Adenoidectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • amount of post op narcotic use [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • degree of nausea and vomiting [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose ketamine given
 Drug: ketamine
Single IV dose of 0.1 mg/kg of ketamine
Placebo Comparator: 2
Saline given as control
 Drug: Placebo
Saline given of equal volume to drug

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587665

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gregory Schears, md Mayo Clinic, Rochester, MN
  More Information

No publications provided

Responsible Party: Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
ClinicalTrials.gov Identifier: NCT00587665     History of Changes
Other Study ID Numbers: 1896-05
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pain

Additional relevant MeSH terms:
Ketamine
Fentanyl
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 18, 2013