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N/A N=102 Randomized Quadruple-blind Treatment

Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain

Chronic Low Back Pain

Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Morphine Consumption in the First 48 Hours After Surgery — 309; 195 mg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Ketamine (Drug); Normal saline (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Dartmouth-Hitchcock Medical Center
Primary completion
Apr 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Morphine Consumption in the First 48 Hours After Surgery
309; 195
SECONDARY
Hospital Duration
4571; 4364
SECONDARY
Hemodynamic Changes - Heart Rate
77.3; 74; 91.4; 87.6; 98.6; 99.8
SECONDARY
Hemodynamic Changes - Blood Pressure
133.8; 132.2; 81.3; 77.3; 139.6; 139.9
SECONDARY
Percentage of Participants With Complications/Adverse Events
22.5; 26.9; 12.2; 15.4; 2.0; 1.9

Summary

Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions (3). Spine surgery provides a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid consumption in patients with chronic pain. The goal of this double blinded, prospective, randomized placebo controlled trial is to quantify the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to postoperative opioid use.

Eligibility Criteria

Inclusion Criteria

  • Laminectomy procedures.
  • History of chronic back pain.
  • Daily opioid use.
  • Capable of providing informed consent.

Exclusion Criteria

  • Intolerance/allergy to ketamine.
  • Intolerance/true allergy to morphine.
  • Elevated intra-ocular pressure.
  • Uncontrolled hypertension.
  • Elevated intra-cranial pressure.
  • Any history of a psychosis.
  • Pregnancy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00899600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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