Pain Management in ED for Incision and Drainage of Abscess

NCT01881997 | Withdrawn Phase 4

• 1 other identifier: 11-001068
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abscess

Keywords

Procedure; Abscess; Emergency Department; Opioid; Fentanyl

Outcome Measures

Primary Outcomes (2)

• 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.

  Participants will be followed for the duration of hospital stay

• 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:

  Participants will be followed for the duration of hospital stay

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

IM normal saline

Drug: Normal Saline

Fentanyl

EXPERIMENTAL

IM Fentanyl

Drug: Fentanyl

Interventions

Fentanyl DRUG

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

Fentanyl

Normal Saline DRUG

IM normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (10)

• 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.

  PMID: 2803357 RESULT

• 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.

  PMID: 11555797 RESULT

• 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.

  PMID: 21197290 RESULT

• 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.

  PMID: 21063553 RESULT

• 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.

  PMID: 18826731 RESULT

• 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.

  PMID: 12487041 RESULT

• 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.

  PMID: 7862469 RESULT

• 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.

  PMID: 9491040 RESULT

• 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.

  PMID: 19388915 RESULT

• 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.

  PMID: 18090011 RESULT

MeSH Terms

Conditions

Abscess; Emergencies

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Larry J Baraff, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Joshua W Elder, B.S.

  University of California, Los Angeles

  STUDY DIRECTOR

• Adaira Landry, B.A.

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: June 20, 2013
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 20, 2013

Record last verified: 2013-06