Clinical Trials Directory

Trials / Completed

CompletedNCT02306759

Ketamine For Acute Treatment of Pain in Emergency Department

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
60 (actual)
Sponsor
The Brooklyn Hospital Center · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department. The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.

Detailed description

The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.

Conditions

Interventions

TypeNameDescription
DRUGKetamineKetamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
DRUGPlaceboNormal saline 50ml, administered over 15 minutes

Timeline

Start date
2015-01-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2014-12-03
Last updated
2017-08-09
Results posted
2017-06-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02306759. Inclusion in this directory is not an endorsement.