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Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children

This study has been completed.
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University Identifier:
First received: February 2, 2012
Last updated: August 20, 2015
Last verified: August 2015

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.

Condition Intervention Phase
Drug: Intranasal Fentanyl
Drug: Intravenous Morphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Score on the Observational Scale of Behavioral Distress Revised (OSBD-R) [ Time Frame: Up to 10 minutes after the procedure completion ]
    Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The scores documented here are the total OSBD-R scores.

Secondary Outcome Measures:
  • Score on the Faces Pain Scale Revised (FPS-R) [ Time Frame: Up to 10 minutes after procedure completion ]
    The Faces Pain Scale Revised (FPS-R) has been validated in patients 4 - 16 years of age undergoing painful procedures and will be used to assess patients' self reported pain. Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.

  • Score on Likert Scale for Patient Satisfaction [ Time Frame: 10 minutes after procedure completion ]
    Patient satisfaction will be measured on a Likert scale just prior to Emergency Department discharge. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey.

Enrollment: 20
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Fentanyl

Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Drug: Intranasal Fentanyl
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
Other Name: Fentanyl
Active Comparator: Intravenous Morphine

Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Drug: Intravenous Morphine
Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Other Name: Morphine


Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01549002

United States, New York
Alexandra & Steven Cohen Children's Emergency Department of Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Daniel Tsze, MD, MPH Columbia University
Study Director: Peter Dayan, MD, MSc Columbia University
Principal Investigator: Daniel Fenster, MD Columbia University
  More Information

Additional Information:
Responsible Party: Daniel Sing-Kwong Tsze, Assistant Professor of Clinical Pediatrics, Columbia University Identifier: NCT01549002     History of Changes
Other Study ID Numbers: AAAI0699
Study First Received: February 2, 2012
Results First Received: February 2, 2015
Last Updated: August 20, 2015

Keywords provided by Columbia University:
Administration intranasal
Infusions intravenous

Additional relevant MeSH terms:
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on May 22, 2017