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Completed

NCT Number: NCT01325493

Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

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.

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Key information

Conditions

Idiopathic Scoliosis Bone Diseases Hyperalgesia Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Scoliosis Sensation Disorders Signs and Symptoms Somatosensory Disorders Spinal Curvatures Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ketamine

Drug

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 names: Ketanest, Ketaset, and Ketalar

normal saline

Drug

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 names: 0.90% NaCl

Primary outcomes

  1. 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 outcomes

  1. Sedation Score

    Time frame: 24, 48, 72, 96 hours post operatively

    Sedation scores 0 = completely awake

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Julia Finkel

Other

Registry information

Official study title

Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents

Acronym: KPSF

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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