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Pain Management in ED for Incision and Drainage of Abscess

Primary Purpose

Abscess

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl
Normal Saline
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring Procedure, Abscess, Emergency Department, Opioid, Fentanyl

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Normal Saline

    Fentanyl

    Arm Description

    IM normal saline

    IM Fentanyl

    Outcomes

    Primary Outcome Measures

    Highest level of pain during the incision and drainage of the abscess
    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
    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:

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2011
    Last Updated
    June 17, 2013
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01881997
    Brief Title
    Pain Management in ED for Incision and Drainage of Abscess
    Official Title
    Randomized Controlled Trial of the Use of Intramuscular Fentanyl for the Incision and Drainage of Abscess in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    IRB modifications made study impractical.
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2011 (Anticipated)
    Study Completion Date
    December 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abscess
    Keywords
    Procedure, Abscess, Emergency Department, Opioid, Fentanyl

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    IM normal saline
    Arm Title
    Fentanyl
    Arm Type
    Experimental
    Arm Description
    IM Fentanyl
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    Fentanyl Intramuscular (IM), 1ugm/kg, x1
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    IM normal saline
    Primary Outcome Measure Information:
    Title
    Highest level of pain during the incision and drainage of the abscess
    Description
    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.
    Time Frame
    Participants will be followed for the duration of hospital stay
    Title
    Safety of Intramuscular Injection of Fentanyl
    Description
    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:
    Time Frame
    Participants will be followed for the duration of hospital stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Larry J Baraff, MD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Joshua W Elder, B.S.
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Adaira Landry, B.A.
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2803357
    Citation
    Wilson JE, Pendleton JM. Oligoanalgesia in the emergency department. Am J Emerg Med. 1989 Nov;7(6):620-3. doi: 10.1016/0735-6757(89)90286-6.
    Results Reference
    result
    PubMed Identifier
    11555797
    Citation
    Fosnocht DE, Swanson ER, Bossart P. Patient expectations for pain medication delivery. Am J Emerg Med. 2001 Sep;19(5):399-402. doi: 10.1053/ajem.2001.24462.
    Results Reference
    result
    PubMed Identifier
    21197290
    Citation
    Motov SM, Khan AN. Problems and barriers of pain management in the emergency department: Are we ever going to get better? J Pain Res. 2008 Dec 9;2:5-11.
    Results Reference
    result
    PubMed Identifier
    21063553
    Citation
    Downey LV, Zun LS. Pain management in the emergency department and its relationship to patient satisfaction. J Emerg Trauma Shock. 2010 Oct;3(4):326-30. doi: 10.4103/0974-2700.70749.
    Results Reference
    result
    PubMed Identifier
    18826731
    Citation
    Yanuka M, Soffer D, Halpern P. An interventional study to improve the quality of analgesia in the emergency department. CJEM. 2008 Sep;10(5):435-9. doi: 10.1017/s1481803500010526.
    Results Reference
    result
    PubMed Identifier
    12487041
    Citation
    Fry M, Holdgate A. Nurse-initiated intravenous morphine in the emergency department: efficacy, rate of adverse events and impact on time to analgesia. Emerg Med (Fremantle). 2002 Sep;14(3):249-54. doi: 10.1046/j.1442-2026.2002.00339.x.
    Results Reference
    result
    PubMed Identifier
    7862469
    Citation
    Schechter NL, Weisman SJ, Rosenblum M, Bernstein B, Conard PL. The use of oral transmucosal fentanyl citrate for painful procedures in children. Pediatrics. 1995 Mar;95(3):335-9.
    Results Reference
    result
    PubMed Identifier
    9491040
    Citation
    Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful procedures in children. Arch Pediatr Adolesc Med. 1998 Feb;152(2):147-9. doi: 10.1001/archpedi.152.2.147.
    Results Reference
    result
    PubMed Identifier
    19388915
    Citation
    O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.
    Results Reference
    result
    PubMed Identifier
    18090011
    Citation
    Curtis KM, Henriques HF, Fanciullo G, Reynolds CM, Suber F. A fentanyl-based pain management protocol provides early analgesia for adult trauma patients. J Trauma. 2007 Oct;63(4):819-26. doi: 10.1097/01.ta.0000240979.31046.98.
    Results Reference
    result

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    Pain Management in ED for Incision and Drainage of Abscess

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