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Pain Management in ED for Incision and Drainage of Abscess

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ClinicalTrials.gov Identifier: NCT01881997
Recruitment Status : Withdrawn (IRB modifications made study impractical.)
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Larry J. Baraff, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE April 1, 2011
First Posted Date  ICMJE June 20, 2013
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • Highest level of pain during the incision and drainage of the abscess [ Time Frame: Participants will be followed for the duration of hospital stay ]
    After the procedure the following question will be asked via a survey: On a scale of 1-10 with 10 being the worst possible pain, what was your highest level of pain during the incision and drainage of the abscess? The answer will be collected via a visual analog scale.
  • Safety of Intramuscular Injection of Fentanyl [ Time Frame: Participants will be followed for the duration of hospital stay ]
    All patients will be monitored to see if any of the following occur after administration of Fentanyl: Adverse effects
    • decreased oxygen saturation <95%
    • respiratory depression
    • bradycardia
    • hypotension
    • anaphylaxis or laryngospasm or bronchoconstriction
    • muscle rigidity
    • other:
    Side effects
    • nausea
    • itching
    • drowsiness
    Treatment needed
    • O2
    • IV Fluids
    • Medications: Specify name and dose
    • Other, specify:
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Management in ED for Incision and Drainage of Abscess
Official Title  ICMJE Randomized Controlled Trial of the Use of Intramuscular Fentanyl for the Incision and Drainage of Abscess in the Emergency Department
Brief 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.

Detailed Description

Patients presenting with painful procedures in the Emergency Department (ED) have been shown to frequently have inadequate pain management. The incision and drainage of an abscess is a common procedure that is usually treated by emergency physicians with only localized anesthetic for pain management. For those abscesses that require incision and drainage, a physician will usually inject a local anesthetic to help decrease sensation to the affected area prior to incision and drainage. Occasionally, physicians will administer a systemic pain medication, in addition to the localized anesthetic, as a method to better help alleviate pain associated with more complex procedures.

Wilson and Pendleton (1989) wrote a landmark study that highlighted the problem of physicians undertreating patients pain in the ED, a problem known as oligoanalgesia. They found that only 50% of patients with moderate to severe pain were receiving narcotics. Since then the literature has highlighted a number of additional deficits in the use of pain medication in the ED to include the amount of time it takes patients to receive medication, the lack of education medical personnel receive in pain management, the bias that physicians have toward using pain medication, and the lack of pain medication given for painful procedures. Five areas of inadequate management of painful conditions in the ED include 1) failure to acknowledge pain, 2) failure to assess initial pain, 3) failure to have pain management guidelines, 4) failure to document pain and assess treatment adequacy, and 5) failure to meet patients expectations. The use of adequate pain medication for painful procedures covers has been a recent attempt to fill in the gap of one area contributing to oligoanalgesia.

Incision and drainage procedures are a common condition that emergency physicians manage yet there is no evidence to suggest whether they are appropriately managing the pain associated with their treatment. We propose a trial to determine whether intramuscular (IM) Fentanyl, given prior to the incision and drainage of the abscess, decreases the level of pain during/after the procedure and increases the patients overall satisfaction with the procedure.

This double blind protocol will randomize 50 patients with abscesses to receive either a combination of an intramuscular injection of Fentanyl followed by subcutaneous (SC) local bupivacaine analgesia (Fentanyl Group), or a combination of an intramuscular injection of normal saline (Control Group) IM followed by SC local bupivacaine analgesia. Patients will receive a questioner administered by a research assistant after the procedure to assess outcomes of study.

Neither treating physicians, nurses nor patients and research assistants will be aware to which group the patient has been randomized. Fentanyl was chosen due to the rapidity of onset (7-8 minutes) and clearance (1-2 hours). The choice of abscess was made given the ease at which to make a diagnosis, standard treatment with incision and drainage and known association with pain during and after the procedure.

After appropriate identification, screening, and consenting, the patient will then be randomized to receive intramuscular Fentanyl (1 ug/kg) OR Normal Saline (1.5 ml) 7-8 minutes before the procedure is began. Patients in either group will still receive usual care with local subcutaneous bupivacaine anesthetics. Patients are at liberty to request more local subcutaneous bupivacaine and or more pain systemic pain medication and the treating provider may deliver more at their discretion. Contamination may occur if patients receiving IM Normal Saline request systemic narcotics for pain levels not controlled with local bupivacaine alone. These patients may receive systemic narcotics again at the discretion of treating providers. However all patients will remain in the initial group to which they were assigned and data will be evaluated on an intention to treat analysis basis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abscess
Intervention  ICMJE
  • Drug: Fentanyl
    Fentanyl Intramuscular (IM), 1ugm/kg, x1
  • Drug: Normal Saline
    IM normal saline
Study Arms  ICMJE
  • Placebo Comparator: Normal Saline
    IM normal saline
    Intervention: Drug: Normal Saline
  • Experimental: Fentanyl
    IM Fentanyl
    Intervention: Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18 and < 65 years
  • Presenting with a simple abscesses requiring incision and drainage
  • Treating physician has to state that the patient's usual treatment would not include systemic opioids before incision and drainage.

Exclusion Criteria:

  • Patients are unable to consent to procedure the procedure
  • Patients are less than age 18 or older than age 65
  • Patients are unable to avoid driving for 2 hours after administration of the intramuscular medication (Fentanyl or placebo)
  • Patients have hypersensitivity or allergy to Fentanyl
  • Patients are pregnant
  • Patients have taken a narcotic pain medication in the last 14 days
  • Patients have a history of drug or alcohol addiction
  • Patients have taken an monoamine oxidase (MAO) inhibitor in the last 14 days (such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)
  • Patients have a breathing disorder such as chronic obstructive pulmonary disease
  • Patients have a history of head injury or brain tumor
  • Patients have a heart rhythm disorder
  • Patients have seizures or epilepsy
  • Patients have mental illness such as depression, hallucinations
  • Patients have low blood pressure
  • Patients have liver or kidney disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881997
Other Study ID Numbers  ICMJE 11-001068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry J. Baraff, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Larry J Baraff, MD University of California, Los Angeles
Study Director: Joshua W Elder, B.S. University of California, Los Angeles
Study Director: Adaira Landry, B.A. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP