Pain Management in ED for Incision and Drainage of Abscess

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: April 1, 2011
• First Posted Date: June 20, 2013
• Last Update Posted Date: June 20, 2013
• Study Start Date: June 2011
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Abscess

Intervention

• Drug: Fentanyl
  Fentanyl Intramuscular (IM), 1ugm/kg, x1
• Drug: Normal Saline
  IM normal saline

Study Arms

• Placebo Comparator: Normal Saline
  IM normal saline
  Intervention: Drug: Normal Saline
• Experimental: Fentanyl
  IM Fentanyl
  Intervention: Drug: Fentanyl

Publications *

• Wilson JE, Pendleton JM. Oligoanalgesia in the emergency department. Am J Emerg Med. 1989 Nov;7(6):620-3.
• Fosnocht DE, Swanson ER, Bossart P. Patient expectations for pain medication delivery. Am J Emerg Med. 2001 Sep;19(5):399-402.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 17, 2013): 0
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 2011
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01881997
• Other Study ID Numbers: 11-001068
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Larry J. Baraff, University of California, Los Angeles
• Study Sponsor: University of California, Los Angeles
• Collaborators: Not Provided

Investigators

• 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