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Ketamine Patient-Controlled Analgesia for Acute Pain

NCT ID: NCT02062879

Last Updated: 2017-09-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pain Multiple Trauma Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketamine

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine administered as patient-controlled analgesia.

Hydromorphone

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

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

Hydromorphone administered as patient-controlled analgesia.

Interventions

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Ketamine

Ketamine administered as patient-controlled analgesia.

Intervention Type DRUG

Hydromorphone

Hydromorphone administered as patient-controlled analgesia.

Intervention Type DRUG

Other Intervention Names

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Ketalar Dilaudid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Sheila Takieddine

Policy Development Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheila C Takieddine, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

UC Health

Eric W Mueller, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

UC Health

Locations

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29605036 (View on PubMed)

Other Identifiers

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Mueller2014

Identifier Type: -

Identifier Source: org_study_id