Ketamine Patient-Controlled Analgesia for Acute Pain

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02062879
• Other study ID #: Mueller2014
• Status: Terminated
• Phase: Phase 3
• First received: February 11, 2014
• Last updated: August 21, 2017
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Fractures
• Multiple Trauma
• Wounds and Injuries

Intervention

Drug:
• Ketamine
Ketamine administered as patient-controlled analgesia.
• Hydromorphone
Hydromorphone administered as patient-controlled analgesia.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breakthrough Daily Opioid Requirement	Breakthrough daily opioid requirement in milligrams of morphine equivalents/day	Participants will be followed for their entire hospital stay, an expected average of 1 week
Secondary	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.	Participants will be followed for their entire hospital stay, an expected average of 1 week