Sub-dissociative Dose Ketamine Dosing Study

Loyola University

Status and phase: Completed; Phase 4

Conditions: Acute Pain

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03714620

211328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups

0.15 mg/kg IV Ketamine

Active Comparator group

Treatment:

Drug: Ketamine

0.3 mg/kg IV Ketamine

Active Comparator group

Treatment:

Drug: Ketamine