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.
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
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.
Intervention / Treatment
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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
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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
Condition or Disease
- Idiopathic Scoliosis
- Spondylolisthesis
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 10 Years to 18 Years |
| Enrollment: | 54 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Jan 01, 2010 | |
|---|---|---|
| Primary Completion: | May 01, 2012 | ACTUAL |
| Completion Date: | Sep 01, 2012 | ACTUAL |
| Study First Posted: | Mar 29, 2011 | ESTIMATED |
| Results First Posted: | Nov 01, 2015 | ESTIMATED |
| Last Updated: | Dec 14, 2015 |
Sponsors / Collaborators
Lead Sponsor:
Julia Finkel
Responsible Party:
Julia Finkel
Participant Groups
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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
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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
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 10 |
| Maximum Age: | 18 |
| Age Groups: | Child / Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. The subject is 10 to 18 years of age
2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
3. The subject is scheduled for elective posterior spinal fusion and instrumentation.
4. The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion Criteria:
1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
2. The subject is pregnant or nursing.
3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine
5. The subject is an ASA classification of 4 or greater (See Appendix I)
6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
8. The subject had a recent opioid exposure (within 1 month of surgery)
9. The subject is obese (body mass index \>30kg/m2)
10. The subject is planned for elective postoperative ventilation
11. The subject has a known ocular disease not permitting pupillometric examination
12. The subject has used any investigation products in the past 30 days
1. The subject is 10 to 18 years of age
2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
3. The subject is scheduled for elective posterior spinal fusion and instrumentation.
4. The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion Criteria:
1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
2. The subject is pregnant or nursing.
3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine
5. The subject is an ASA classification of 4 or greater (See Appendix I)
6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
8. The subject had a recent opioid exposure (within 1 month of surgery)
9. The subject is obese (body mass index \>30kg/m2)
10. The subject is planned for elective postoperative ventilation
11. The subject has a known ocular disease not permitting pupillometric examination
12. The subject has used any investigation products in the past 30 days
Primary Outcomes
Secondary Outcomes
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Sedation scores 0 = completely awake 1. = sleepy but responds appropriately 2. = somnolent but arouses to light stimuli 3. = asleep but responsive to deeper physical stimuli 4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.
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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.
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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.
More Details
| NCT Number: | NCT01325493 |
|---|---|
| Acronym: | KPSF |
| Other IDs: | 4735 |
| Study URL: | https://clinicaltrials.gov/study/NCT01325493 |
Last updated: Sep 29, 2023