Clinical trial NCT01549002: Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
Official title: Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abscess
Pain
Keywords: Abscess
Pain
Administration intranasal
Infusions intravenous
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children can develop abscesses (a collection of pus under their skin) that require a physician to cut it open to let the pus drain out. This is a painful procedure. Most medical professionals will use numbing cream and inject numbing medicine into the skin, just like at the dentist, to help reduce the pain. While this helps minimize the pain of cutting the skin, it doesn't help the pain associated with draining out the pus.

There are many strategies and medications available to physicians to help decrease the pain of this procedure. Most of the medications available to treat the pain require the placement of an intravenous (IV) catheter through the patient's skin, which itself is a painful procedure. In the investigators emergency department, many patients with abscesses that need a procedure to drain the pus receive a medicine called morphine through an IV.

Some pain medicines, however, can be sprayed into a patient's nose, and have been shown to be helpful at reducing the pain of a broken bone or a burn. These medicines do not require the placement of an IV.

The purpose of this research study is to determine whether a medicine called fentanyl, when sprayed into the nose of patients aged 4 to 18 years undergoing abscess drainage, is not worse than IV morphine in decreasing the pain of the procedure.

After the risks and benefits of the study are explained to patients and their parents, written informed consent will be obtained. Written informed assent will be obtained for patients older than 8 years of age. Like the flipping of a coin, a computer program will decide randomly which half of the patients will receive fentanyl nose spray and which half will receive morphine by IV.

The patients assigned to receive fentanyl nose spray will not have an IV placed. The patients assigned to receive morphine will have an IV placed. Both groups of patients will have the abscess drainage procedure done the same way. All patients will be videotaped in order to score their pain by a trained observer. This score is the main outcome (measurement) in the study.


Eligibility criteria: Inclusion Criteria:

* Patient is 4 years of age up to their 18th birthday
* Patient has a cutaneous abscess for which an I\&D is to be performed

Exclusion Criteria:

* Patient's parent doesn't speak English or Spanish
* Patient has developmental delay or neurological impairment
* Patient has altered mental status
* Known hypersensitivity to study drugs (fentanyl, morphine sulfate, lidocaine, LMX4®)
* The presence of significant blood or mucous in the nares despite blowing nose or suctioning
* Severe renal or liver dysfunction, signs of respiratory distress or depression, any respiratory distress, chronic and severe asthma, upper airway obstruction, suspected gastrointestinal obstruction, suspected paralytic ileus
* Narcotic analgesia within 4 hours of ED physician evaluation
* Need for moderate sedation, deep sedation, or general anesthesia
* Need for subspecialty consultation to perform the I\&D
* Need for I\&D of more than 1 skin abscess
* Cutaneous abscesses located on the genitals, breasts, face, or neck
* Previous enrollment in the study
* Patients with chronic pain syndromes (sickle cell disease, cancer, arthritis, inflammatory bowel disease)

Primary outcomes:
measure: Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)
timeFrame: Up to 10 minutes after the procedure completion
Secondary outcomes:
measure: Score on the Faces Pain Scale Revised (FPS-R)
timeFrame: Up to 10 minutes after procedure completion
measure: Number of Patients Satisfied With Analgesia Administered
timeFrame: 10 minutes after procedure completion
Other outcomes:
Locations:
city: New York
country: United States
facility: Alexandra & Steven Cohen Children's Emergency Department of Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Daniel Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Peter Dayan, MD, MSc
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Daniel Fenster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fenster DB, Dayan PS, Babineau J, Aponte-Patel L, Tsze DS. Randomized Trial of Intranasal Fentanyl Versus Intravenous Morphine for Abscess Incision and Drainage. Pediatr Emerg Care. 2018 Sep;34(9):607-612. doi: 10.1097/PEC.0000000000000810.