Sub-dissociative Dose Ketamine Dosing Study

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: Ketamine

• Registration Number: NCT03714620
• Lead Sponsor: Loyola University

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.

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 Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Results First Submitted: 2022-05-09
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Results First Posted: 2022-08-09
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.15 mg/kg IV Ketamine	Ketamine	-
0.3 mg/kg IV Ketamine	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration	30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Need Additional Pain Medication at 30 Minutes	30 minutes	Patient request for additional pain medications at 30 minutes post initiation of drug administration
Change in Pain Score From Baseline to 60 Minutes	60 minutes	Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Number of Patients Who Need Rescue Medications at 60 Minutes	60 minutes	Patient request for additional pain medications at 60 minutes
Adverse Effects at 30 Min	30 minutes	Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Change in Pain Score From Baseline to 15 Minutes	15 minutes	Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States