NCT03714620

Sub-dissociative Dose Ketamine Dosing Study

A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2018-10-22
• Last updated: 2022-08-09
• Results posted: 2022-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study