Phase 4 N=98 Randomized Quadruple-blind Treatment

Sub-dissociative Dose Ketamine Dosing Study

Acute Pain

Bottom Line

View on ClinicalTrials.gov: NCT03714620 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration — 3.8; 3.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketamine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Loyola University
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration	3.8; 3.5	—
SECONDARY Change in Pain Score From Baseline to 15 Minutes	3.6; 4.8	—
SECONDARY Change in Pain Score From Baseline to 60 Minutes	3.7; 3.5	—
SECONDARY Number of Participants Who Need Additional Pain Medication at 30 Minutes	1; 0	—
SECONDARY Number of Patients Who Need Rescue Medications at 60 Minutes	2; 4	—
SECONDARY Adverse Effects at 30 Min	18; 20; 21; 16; 16; 11	—

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.

Eligibility 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 180 mm Hg, pulse rate 150 beats/minute, and respiration rate 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03714620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.