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Ketamine Patient-Controlled Analgesia for Acute Pain

Primary Purpose

Acute Pain, Multiple Trauma, Fractures

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Hydromorphone

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring pain, trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age greater than or equal to 18 years
Total Injury Severity Score greater than 9
Functioning intravenous catheter present per standard of care
Patient planned to receive PCA for acute pain per standard of care
Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
Negative pregnancy test for women of childbearing age

Exclusion Criteria:

Body mass index greater than 35
History of active psychiatric disease
Acute or chronic liver or renal failure
History of heart failure or coronary artery disease
Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
Patients who abuse alcohol and are at high risk for alcohol withdrawal
Intubated patients
Glasgow Coma Scale score less than 13, or motor subscore less than 6
Documented allergy to ketamine, hydromorphone, or lorazepam
Pregnancy
Incarceration

Sites / Locations

University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Hydromorphone

Arm Description

Ketamine 90mg/30 mL PCA (3 mg/mL)

Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)

Outcomes

Primary Outcome Measures

Total Daily Opioid Requirement

Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

Secondary Outcome Measures

Breakthrough Daily Opioid Requirement

Breakthrough daily opioid requirement in milligrams of morphine equivalents/day

Median Pain Score

Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.

Full Information

NCT ID

NCT02062879

First Posted

February 11, 2014

Last Updated

August 21, 2017

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT02062879

Brief Title

Ketamine Patient-Controlled Analgesia for Acute Pain

Official Title

Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

Withdrawals from study due to anticipated effects from study drugs

Study Start Date

April 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.

6. Conditions and Keywords

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

Acute Pain, Multiple Trauma, Fractures

Keywords

pain, trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Ketamine 90mg/30 mL PCA (3 mg/mL)

Arm Title

Hydromorphone

Arm Type

Active Comparator

Arm Description

Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

Ketalar

Intervention Description

Ketamine administered as patient-controlled analgesia.

Intervention Type

Drug

Intervention Name(s)

Hydromorphone

Other Intervention Name(s)

Dilaudid

Intervention Description

Hydromorphone administered as patient-controlled analgesia.

Primary Outcome Measure Information:

Title

Total Daily Opioid Requirement

Description

Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

Time Frame

Participants will be followed for their entire hospital stay, an expected average of 1 week.

Secondary Outcome Measure Information:

Title

Breakthrough Daily Opioid Requirement

Description

Breakthrough daily opioid requirement in milligrams of morphine equivalents/day

Time Frame

Participants will be followed for their entire hospital stay, an expected average of 1 week

Title

Median Pain Score

Description

Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.

Time Frame

Participants will be followed for their entire hospital stay, an expected average of 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age greater than or equal to 18 years Total Injury Severity Score greater than 9 Functioning intravenous catheter present per standard of care Patient planned to receive PCA for acute pain per standard of care Patient ability to effectively use a PCA device as assessed by the primary attending trauma service Negative pregnancy test for women of childbearing age Exclusion Criteria: Body mass index greater than 35 History of active psychiatric disease Acute or chronic liver or renal failure History of heart failure or coronary artery disease Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy Patients who abuse alcohol and are at high risk for alcohol withdrawal Intubated patients Glasgow Coma Scale score less than 13, or motor subscore less than 6 Documented allergy to ketamine, hydromorphone, or lorazepam Pregnancy Incarceration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila C Takieddine, Pharm.D.

Organizational Affiliation

UC Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric W Mueller, Pharm.D.

Organizational Affiliation

UC Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29605036

Citation

Takieddine SC, Droege CA, Ernst N, Droege ME, Webb M, Branson RD, Gerlach TW, Robinson BRH, Johannigman JA, Mueller EW. Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients. J Surg Res. 2018 May;225:6-14. doi: 10.1016/j.jss.2017.12.019. Epub 2018 Jan 8.

Results Reference

derived

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Ketamine Patient-Controlled Analgesia for Acute Pain

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