Pain Management in ED for Incision and Drainage of Abscess

NCT ID: NCT01881997

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Normal Saline

IM normal saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

IM normal saline

Fentanyl

IM Fentanyl

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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

Interventions

Fentanyl

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

Intervention Type: DRUG

Normal Saline

IM normal saline

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Larry J. Baraff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry J Baraff, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Joshua W Elder, B.S.

Role: STUDY_DIRECTOR

University of California, Los Angeles

Adaira Landry, B.A.

Role: STUDY_DIRECTOR

University of California, Los Angeles

References

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Reference Type: RESULT

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Other Identifiers

11-001068

Identifier Type: -

Identifier Source: org_study_id