Ketamine Patient-Controlled Analgesia for Acute Pain

NCT02062879 | Terminated Phase 3 Results

• 1 other identifier: Mueller2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Multiple Trauma; Fractures

Keywords

pain; trauma

Outcome Measures

Primary Outcomes (1)

• Total Daily Opioid Requirement

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

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

Secondary Outcomes (2)

• Breakthrough Daily Opioid Requirement

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

• Median Pain Score

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

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Hydromorphone

ACTIVE COMPARATOR

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

Drug: Hydromorphone

Interventions

Ketamine DRUG

Ketamine administered as patient-controlled analgesia.

Also known as: Ketalar

Ketamine

Hydromorphone DRUG

Hydromorphone administered as patient-controlled analgesia.

Also known as: Dilaudid

Hydromorphone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 29605036 DERIVED

MeSH Terms

Conditions

Acute Pain; Multiple Trauma; Fractures, Bone; Pain; Wounds and Injuries

Interventions

Ketamine; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Sheila Takieddine
• Organization: UC Health University of Cincinnati Medical Center

Sheila.Takieddine@UCHealth.com

513-585-6195

Study Officials

• Sheila C Takieddine, Pharm.D.

  UC Health

  PRINCIPAL INVESTIGATOR

• Eric W Mueller, Pharm.D.

  UC Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Policy Development Specialist

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 14, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 21, 2017
• Results First Posted: September 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)