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

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ClinicalTrials.gov Identifier: NCT01325493
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : November 1, 2015
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's National Research Institute

Tracking Information
First Submitted Date  ICMJE February 25, 2011
First Posted Date  ICMJE March 29, 2011
Results First Submitted Date  ICMJE June 17, 2015
Results First Posted Date  ICMJE November 1, 2015
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Total opioid use [ Time Frame: up to 5 days ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Pupillometry [ Time Frame: 5 days ]
Baseline pupillometry will be done in the surgical preparation area using the Optometrics infrared pupillometer. Static pupillometry consists of measurement of the initial pupil diameter. Amplitude of constriction, velocity of constriction, velocity of redilatation, latency and duration of reaction are measured as dynamic pupillometric parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Official Title  ICMJE Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Idiopathic Scoliosis
  • Spondylolisthesis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Normal Saline
  • 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
    Intervention: Drug: Ketamine
Publications * Pestieau SR, Finkel JC, Junqueira MM, Cheng Y, Lovejoy JF, Wang J, Quezado Z. Prolonged perioperative infusion of low-dose ketamine does not alter opioid use after pediatric scoliosis surgery. Paediatr Anaesth. 2014 Jun;24(6):582-90. doi: 10.1111/pan.12417.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2015)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2011)
50
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01325493
Other Study ID Numbers  ICMJE 4735
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia Finkel, Children's National Research Institute
Study Sponsor  ICMJE Julia Finkel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pestieau Sophie, MD Children's National Research Institute
Study Director: Finkel C Julie, MD Children's National Research Institute
PRS Account Children's National Research Institute
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP