Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

Spondylolisthesis Clinical Trial

— KPSF  

Official title:

Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325493
• Other study ID #: 4735
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: December 14, 2015
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2015
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperalgesia
• Idiopathic Scoliosis
• Scoliosis
• Spondylolisthesis

Intervention

Drug:
• Ketamine
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
• Normal Saline
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

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Julia Finkel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sedation Score	Sedation scores 0 = completely awake; = sleepy but responds appropriately; = somnolent but arouses to light stimuli; = asleep but responsive to deeper physical stimuli; = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.	24, 48, 72, 96 hours post operatively	No
Secondary	Pain Score at Rest	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.	24, 48, 72, 96 hours post operatively	No
Secondary	Pain Score During Cough.	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.	24, 48, 72, 96 hours post operatively	No