Phase 4
N=54
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Idiopathic Scoliosis · Spondylolisthesis
Bottom Line
View on ClinicalTrials.gov: NCT01325493 ↗Enrolled (actual)
54
Serious AEs
2.0%
Results posted
Nov 2015
Primary outcome: Primary: Morphine Equivalent Consumption (mg/kg) — 1.3; 1.36; 1.28; 1.275 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Normal Saline (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Julia Finkel
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Equivalent Consumption (mg/kg) |
1.3; 1.36; 1.28; 1.275; .89; .93 | — |
| SECONDARY Sedation Score |
.73; .75; .62; .54; .38; .3 | — |
| SECONDARY Pain Score at Rest |
3.9; 4.55; 4.53; 5.2; 3.6; 3.48 | — |
| SECONDARY Pain Score During Cough. |
4.5; 5.1; 5.4; 5.45; 4.4; 3.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01325493). 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.