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Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia (KPSF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325493
First Posted: March 29, 2011
Last Update Posted: January 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia Finkel, Children's Research Institute
  Purpose

The purpose of this study is to:

1. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.


Condition Intervention Phase
Idiopathic Scoliosis Spondylolisthesis Drug: Ketamine Drug: Normal Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Julia Finkel, Children's Research Institute:

Primary Outcome Measures:
  • Morphine Equivalent Consumption (mg/kg) [ Time Frame: at 24, 48, 72, 96 hours post operatively ]
    Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.


Secondary Outcome Measures:
  • Sedation Score [ Time Frame: 24, 48, 72, 96 hours post operatively ]

    Sedation scores 0 = completely awake

    1. = sleepy but responds appropriately
    2. = somnolent but arouses to light stimuli
    3. = asleep but responsive to deeper physical stimuli
    4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.

  • Pain Score at Rest [ Time Frame: 24, 48, 72, 96 hours post operatively ]
    Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.

  • Pain Score During Cough. [ Time Frame: 24, 48, 72, 96 hours post operatively ]
    Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.


Enrollment: 54
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
Normal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Drug: Normal Saline
Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Other Name: 0.90% NaCl
Active Comparator: Ketamine
ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Drug: Ketamine
ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Other Name: Ketanest, Ketaset, and Ketalar

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is 10 to 18 years of age
  2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
  3. The subject is scheduled for elective posterior spinal fusion and instrumentation.
  4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

  1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  2. The subject is pregnant or nursing.
  3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
  4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine
  5. The subject is an ASA classification of 4 or greater (See Appendix I)
  6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
  7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
  8. The subject had a recent opioid exposure (within 1 month of surgery)
  9. The subject is obese (body mass index >30kg/m2)
  10. The subject is planned for elective postoperative ventilation
  11. The subject has a known ocular disease not permitting pupillometric examination
  12. The subject has used any investigation products in the past 30 days
  Contacts and Locations
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): NCT01325493


Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Julia Finkel
Investigators
Principal Investigator: Pestieau Sophie, MD Children's Research Institute
Study Director: Finkel C Julie, MD Children's Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julia Finkel, Director of Research, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01325493     History of Changes
Other Study ID Numbers: 4735
First Submitted: February 25, 2011
First Posted: March 29, 2011
Results First Submitted: June 17, 2015
Results First Posted: November 2, 2015
Last Update Posted: January 14, 2016
Last Verified: December 2015

Keywords provided by Julia Finkel, Children's Research Institute:
opioid tolerance
hyperalgesia
scoliosis
pupillometry

Additional relevant MeSH terms:
Scoliosis
Hyperalgesia
Spondylolisthesis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spondylolysis
Spondylosis
Analgesics, Opioid
Ketamine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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