AbscessPhase 4NCT01881997
Pain Management in ED for Incision and Drainage of Abscess
A Phase 4 study testing Fentanyl and Normal Saline in people with Abscess, run by University of California, Los Angeles.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abscess
- What is being tested?
- Fentanyl and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
About this study
Official title: Randomized Controlled Trial of the Use of Intramuscular Fentanyl for the Incision and Drainage of Abscess in the Emergency Department
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl Intramuscular (IM), 1ugm/kg, x1
Normal SalineDrug
IM normal saline
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | IM normal saline Receives: Drug: Normal Saline |
| Fentanyl | Experimental | IM Fentanyl Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
Measured: Participants will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: IRB modifications made study impractical.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry J. Baraff, University of California, Los Angeles
- Investigators
- Larry J Baraff, MD, Principal investigator, University of California, Los AngelesJoshua W Elder, B.S., Study director, University of California, Los AngelesAdaira Landry, B.A., Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881997
- Sponsor's protocol ID
- 11-001068
- Status last verified
- Jun 2013
- First submitted
- 1 Apr 2011
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2803357Fosnocht 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.
PubMed 11555797Motov 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.
PubMed 21197290Downey 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.
PubMed 21063553Yanuka 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.
PubMed 18826731Fry 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.
PubMed 12487041Schechter 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.
PubMed 7862469Weisman 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.
PubMed 9491040O'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.
PubMed 19388915Curtis 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.
PubMed 18090011
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Use of Intramuscular Fentanyl for the Incision and Drainage of Abscess in the Emergency Department
- ClinicalTrials.gov ID
- NCT01881997
- Acronym / sponsor ID
- 11-001068
- Conditions
- Abscess
- Keywords
- Procedure, Abscess, Emergency Department, Opioid, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB modifications made study impractical.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal SalineIM normal saline |
| Fentanyl | Experimental | Drug: FentanylIM Fentanyl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylFentanyl Intramuscular (IM), 1ugm/kg, x1 | Drug | Fentanyl |
| Normal SalineIM normal saline | Drug | Normal Saline |
Primary outcome
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:
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Results publication: PubMed 2803357Wilson 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 publication: PubMed 11555797Fosnocht 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 publication: PubMed 21197290Motov 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 publication: PubMed 21063553Downey 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 publication: PubMed 18826731Yanuka 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 publication: PubMed 12487041Fry 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 publication: PubMed 7862469Schechter 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 publication: PubMed 9491040Weisman 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 publication: PubMed 19388915O'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 publication: PubMed 18090011Curtis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry J Baraff, MD principal investigator
University of California, Los Angeles
Joshua W Elder, B.S. study director
University of California, Los Angeles
Adaira Landry, B.A. study director
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Normal Saline in people with Abscess, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest level of pain during the incision and drainage of the abscess (time frame: Participants will be followed for the duration of hospital stay). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881997, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.