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Pain Management in ED for Incision and Drainage of Abscess

NCT01881997 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-06-20

No results posted yet for this study

Summary

Patients presenting with painful procedures in the Emergency Department (ED) have been shown to frequently have inadequate pain management. The incision and drainage (I\&D) of an abscess is a common procedure that is viewed by many emergency physicians as only requiring a localized anesthetic for pain management. However, it has been documented in previous research that there can be disconnect between what emergency medicine physicians interpret as painful and what patients experience as pain. A trial will be conducted to focus on use of intramuscular (IM) Fentanyl as an intervention to help alleviate pain associated with the incision and drainage of an abscess. This is a procedure that rarely receives systemic opioids.

This double blinded protocol will randomize a total of 50 patients patients with abscesses to receive either a combination of Fentanyl IM followed by subcutaneous (SC) local bupivicaine analgesia or Normal Saline IM followed by SC local bupivicaine analgesia. Only opiate naive patients will be enrolled. The primary outcomes studied are patients overall satisfaction with procedure, and patients level of pain associated with the procedure.

Conditions

Interventions

DRUG

Fentanyl

Fentanyl Intramuscular (IM), 1ugm/kg, x1

DRUG

Normal Saline

IM normal saline

Sponsors & Collaborators

Principal Investigators

  • Larry J Baraff, MD · University of California, Los Angeles

  • Joshua W Elder, B.S. · University of California, Los Angeles

  • Adaira Landry, B.A. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881997 on ClinicalTrials.gov