Sub-dissociative Dose Ketamine Dosing Study

NCT03714620 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 211328
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration

  Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.

  30 minutes

Secondary Outcomes (5)

• Change in Pain Score From Baseline to 15 Minutes

  15 minutes

• Change in Pain Score From Baseline to 60 Minutes

  60 minutes

• Number of Participants Who Need Additional Pain Medication at 30 Minutes

  30 minutes

• Number of Patients Who Need Rescue Medications at 60 Minutes

  60 minutes

• Adverse Effects at 30 Min

  30 minutes

Study Arms (2)

0.15 mg/kg IV Ketamine

ACTIVE COMPARATOR

Drug: Ketamine

0.3 mg/kg IV Ketamine

ACTIVE COMPARATOR

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

0.15 mg/kg IV Ketamine; 0.3 mg/kg IV Ketamine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Shannon Lovett, MD, Associate Professor of Emergency Medicine
• Organization: Trinity Health, Loyola University Medical Center, Stritch School of Medicine

slovett@lumc.edu

7082168705

Study Officials

• Shannon Lovett, MD

  Loyola University Chicago, LUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Department of Emergency Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: October 15, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: August 9, 2022
• Results First Posted: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)