Clinical trial NCT01325493: Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Official title: Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Scoliosis
Spondylolisthesis
Keywords: opioid tolerance
hyperalgesia
scoliosis
pupillometry
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morphine Equivalent Consumption (mg/kg)
timeFrame: at 24, 48, 72, 96 hours post operatively
Secondary outcomes:
measure: Sedation Score
timeFrame: 24, 48, 72, 96 hours post operatively
measure: Pain Score at Rest
timeFrame: 24, 48, 72, 96 hours post operatively
measure: Pain Score During Cough.
timeFrame: 24, 48, 72, 96 hours post operatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Pestieau Sophie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Finkel C Julie, MD
role: STUDY_DIRECTOR
References:
citation: 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.