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Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia (KPSF)

Primary Purpose

Idiopathic Scoliosis, Spondylolisthesis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Normal Saline

About this trial

This is an interventional prevention trial for Idiopathic Scoliosis focused on measuring opioid tolerance, hyperalgesia, scoliosis, pupillometry

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's National Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal Saline

Ketamine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01325493

First Posted

February 25, 2011

Last Updated

December 14, 2015

Sponsor

Julia Finkel

1. Study Identification

Unique Protocol Identification Number

NCT01325493

Brief Title

Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

Acronym

KPSF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Julia Finkel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Scoliosis, Spondylolisthesis

Keywords

opioid tolerance, hyperalgesia, scoliosis, pupillometry

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Ketamine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

Ketanest, Ketaset, and Ketalar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Other Intervention Name(s)

0.90% NaCl

Intervention Description

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

Primary Outcome Measure Information:

Title

Morphine Equivalent Consumption (mg/kg)

Description

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.

Time Frame

at 24, 48, 72, 96 hours post operatively

Secondary Outcome Measure Information:

Title

Sedation Score

Description

Time Frame

24, 48, 72, 96 hours post operatively

Title

Pain Score at Rest

Description

Time Frame

24, 48, 72, 96 hours post operatively

Title

Pain Score During Cough.

Description

Time Frame

24, 48, 72, 96 hours post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pestieau Sophie, MD

Organizational Affiliation

Children's National Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Finkel C Julie, MD

Organizational Affiliation

Children's National Research Institute

Official's Role

Study Director

Facility Information:

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24809838

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.

Results Reference

derived

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Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

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