Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
Condition: Abscess; Pain
MeSH terms: Abscess
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): Intranasal Fentanyl; Intravenous Morphine
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Fentanyl; Morphine
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abscess; Pain; Administration intranasal; Infusions intravenous