TerminatedPhase 4ketamine

Ketamine for Pain in the Emergency Department

Sponsored by Hackensack Meridian Health

NCT ID
NCT03896230
Target Enrollment
11 participants
Start Date
2019-05-03
Est. Completion
2019-12-20

About This Study

This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults \< 65 years old and \> 65 years old).

Conditions Studied

Acute Pain

Interventions

  • Ketamine Injectable Product

Eligibility

Age:21 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Acute pain (including acute on chronic pain)
* Pain score of moderate to severe (\> 4/10) on the Numerical Rating Scale
* Provider determines the patient requires intravenous ketamine for analgesia

Exclusion Criteria:

* History of hypersensitivity to ketamine
* Altered mental status
* Psychiatric illness
* Known history of renal or hepatic insufficiency
* Acute head or eye injury
* Suspected intracranial hypertension or mass
* Headache as the chief complaint
* Alcohol or drug abuse
* Received an analgesic within the last four hours
* History of congestive heart failure
* History of aortic or brain aneurysm
* Active Chest Pain
* Porphyria
* Active methadone treatment
* Pregnant or breastfeeding
* Signs of respiratory, hemodynamic, or neurologic compromise

  * Systolic blood pressure \< 90 mmHg or \> 180 mmHg
  * Heart rate \< 50 beats per minute or \> 150 beats per minute
  * Respiratory rate \< 10 breaths per minute or \> 30 breaths per minute
  * Glasgow Coma Score \< 15
* Previously received ketamine \< 0.3 mg/kg IV for acute pain in the emergency department

Study Locations (1)

Hackensack University Medical Center
Hackensack, New Jersey, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

Ketamine for Pain in the Emergency Department | Huxley