Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

Completed · Phase 4

Conditions studied: Idiopathic Scoliosis, Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT01325493

Run by

Julia Finkel

People needed

54

Starts

2010-01-01

Expected to finish

2012-09-01

Last updated by the study team

2016-01-14

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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