Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

NCT01325493 | Completed Phase 4 Results DMC

• 1 other identifier: 4735
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Scoliosis; Spondylolisthesis

Keywords

opioid tolerance; hyperalgesia; scoliosis; pupillometry

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalent Consumption (mg/kg)

  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.

  at 24, 48, 72, 96 hours post operatively

Secondary Outcomes (3)

• Sedation Score

  24, 48, 72, 96 hours post operatively

• Pain Score at Rest

  24, 48, 72, 96 hours post operatively

• Pain Score During Cough.

  24, 48, 72, 96 hours post operatively

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

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

Ketamine

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Ketanest, Ketaset, and Ketalar

Ketamine

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

Also known as: 0.90% NaCl

Normal Saline

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Julia Finkel: lead

Study Sites (1)

Children's National Medical Center

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

Location

Related Publications (1)

• 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.

  PMID: 24809838 DERIVED

MeSH Terms

Conditions

Spondylolisthesis; Hyperalgesia; Scoliosis

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Patient sex and ethnicity could have led to analytical bias.

Results Point of Contact

• Title: Julia Finkel
• Organization: Children's National Health System

JFINKEL@childrensnational.org

2024764867

Study Officials

• Pestieau Sophie, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Finkel C Julie, MD

  Children's National Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 29, 2011
• Study Start: January 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 14, 2016
• Results First Posted: November 2, 2015

Record last verified: 2015-12

Locations

US (1)