Sub-dissociative Dose Ketamine Dosing Study

• ClinicalTrials.gov Identifier: NCT03714620
• Recruitment Status: Completed
• First Posted: October 22, 2018
• Last Update Posted: October 24, 2019
• Sponsor: Loyola University
• Information provided by (Responsible Party): Shannon Lovett, Loyola University

Study Description

Brief Summary:

Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Drug: Ketamine	Phase 4

Detailed Description:

Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.

Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
• Actual Study Start Date: October 15, 2018
• Actual Primary Completion Date: September 17, 2019
• Actual Study Completion Date: September 17, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 0.15 mg/kg IV Ketamine	Drug: Ketamine; Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Active Comparator: 0.3 mg/kg IV Ketamine	Drug: Ketamine; Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Outcome Measures

Primary Outcome Measures :

1. Reduction in pain score from baseline to 30 minutes post initiation of drug administration [ Time Frame: 30 minutes ]
   Reduction in pain score from time 0 to time 30 min

Secondary Outcome Measures :

1. Reduction in pain score from baseline to 15 minutes [ Time Frame: 15 minutes ]
   Reduction in pain score from time 0 to time 15 min post initiation of drug administration
2. Reduction in pain score from baseline to 60 minutes [ Time Frame: 60 minutes ]
   Reduction in pain score from time 0 to time 60 min post initiation of drug administration
3. Need for rescue medications at 30 minutes [ Time Frame: 30 minutes ]
   Patient request for additional pain medications at 30 minutes post initiation of drug administration
4. Need for rescue medications at 60 minutes [ Time Frame: 60 minutes ]
   Patient request for additional pain medications at 60 minutes
5. Change in heart rate [ Time Frame: 60 minutes ]
6. Change in systolic/diastolic blood pressure [ Time Frame: 60 minutes ]
7. Change in oxygen saturation [ Time Frame: 60 minutes ]
8. Adverse effects at 30 min [ Time Frame: 30 minutes ]
   Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adults ages 18-59
• Weight 45 - 115 kg
• Acute abdominal, flank, back, musculoskeletal pain, or a headache
• Onset of pain within 7 days
• Pain score of 5 or more
• Requiring intravenous analgesia
• Hasn't been enrolled in this study previously

Exclusion Criteria:

• Pregnancy
• Breast-feeding
• Altered mental status rendering the patient unable to consent to the study
• Allergy to ketamine
• Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
• History of acute head or eye injury, seizure, intracranial hypertension
• Chronic pain
• Renal or hepatic insufficiency
• Known alcohol or drug use disorder
• Currently under influence of alcohol/opiates
• Acute psychiatric illness

Contacts and Locations

Locations

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Sponsors and Collaborators

Loyola University

More Information

• Responsible Party: Shannon Lovett, Associate Professor of Department of Emergency Medicine, Loyola University
• ClinicalTrials.gov Identifier: NCT03714620
• Other Study ID Numbers: 211328
• First Posted: October 22, 2018
• Last Update Posted: October 24, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action