Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
Condition: Abscess; Pain
MeSH terms: Abscess
Intervention: Intranasal Fentanyl; Intravenous Morphine
Intervention description: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose; Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Intervention MeSH terms: Fentanyl; Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Pain; Administration intranasal; Infusions intravenous

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)