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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

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ClinicalTrials.gov Identifier: NCT00587665
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : June 14, 2017
Sponsor:
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: ketamine Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. amount of post op narcotic use [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. degree of nausea and vomiting [ Time Frame: 5 days ]


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
ClinicalTrials.gov Identifier: NCT00587665     History of Changes
Other Study ID Numbers: 1896-05
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: December 2007

Keywords provided by Mayo Clinic:
Pain

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