Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

NCT ID: NCT04057989

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-30

Brief Summary

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

Detailed Description

This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.

This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:

Objectives

1. To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.

2. To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.

3. To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.

4. To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.

Conditions

Pain, Acute; Analgesia; Amputation, Traumatic; Post Traumatic Stress Disorder; Trauma, Brain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Battlefield Injury with ketamine treatment

Patients who received ketamine infusions to treat pain from January 2007 to December 2013.

ketamine

Intervention Type: DRUG

Interventions

ketamine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Battlefield injured from January 2007 to December 2013
• Prescribed a ketamine infusion for acute pain
• Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion

Exclusion Criteria

• Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
• No continuous perineural catheter or epidural placement while on ketamine infusion
• Less than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kent, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

399623

Identifier Type: -

Identifier Source: org_study_id