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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01325493
First received: February 25, 2011
Last updated: December 14, 2015
Last verified: December 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Children's Research Institute:

Primary Outcome Measures:
  • Morphine Equivalent Consumption (mg/kg) [ Time Frame: at 24, 48, 72, 96 hours post operatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 
Study First Received: February 25, 2011
Results First Received: June 17, 2015
Last Updated: December 14, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 05, 2016