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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: December 21, 2007
Last updated: June 12, 2017
Last verified: December 2007
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
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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

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

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

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


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

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00587665

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

Responsible Party: Gregory J. Schears, MD, Mayo Clinic, Rochester, MN Identifier: NCT00587665     History of Changes
Other Study ID Numbers: 1896-05
Study First Received: December 21, 2007
Last Updated: June 12, 2017

Keywords provided by Mayo Clinic:

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Adjuvants, Anesthesia processed this record on September 19, 2017