Sub-dissociative Dose Ketamine Dosing Study

Loyola University98 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Pain

Interventions

KetamineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Loyola University Medical Center

Maywood, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes

Secondary Outcomes

Change in Pain Score From Baseline to 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.

Time frame: 15 minutes

Change in Pain Score From Baseline to 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.

Time frame: 60 minutes

Number of Participants Who Need Additional Pain Medication at 30 Minutes

Patient request for additional pain medications at 30 minutes post initiation of drug administration

Time frame: 30 minutes

Number of Patients Who Need Rescue Medications at 60 Minutes

Patient request for additional pain medications at 60 minutes

Time frame: 60 minutes

Adverse Effects at 30 Min

Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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