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

NCT01549002 | Completed Phase 3 Results DMC

• 1 other identifier: AAAI0699
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess; Pain

Keywords

Abscess; Pain; Administration intranasal; Infusions intravenous

Outcome Measures

Primary Outcomes (1)

• Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)

  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 four phases in the study are (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. The scores documented here are the total OSBD-R scores.

  Up to 10 minutes after the procedure completion

Secondary Outcomes (2)

• Score on the Faces Pain Scale Revised (FPS-R)

  Up to 10 minutes after procedure completion

• Number of Patients Satisfied With Analgesia Administered

  10 minutes after procedure completion

Study Arms (2)

Intranasal Fentanyl

EXPERIMENTAL

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

Intravenous Morphine

ACTIVE COMPARATOR

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

Interventions

Intranasal Fentanyl DRUG

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

Also known as: Fentanyl

Intranasal Fentanyl

Intravenous Morphine DRUG

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

Also known as: Morphine

Intravenous Morphine

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Alexandra & Steven Cohen Children's Emergency Department of Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 27387971 RESULT

Related Links

• Educational portal for therapeutic intranasal drug delivery

MeSH Terms

Conditions

Abscess; Pain

Interventions

Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Daniel Fenster
• Organization: ColumbiaU

dbf2114@columbia.edu

212-305-9825

Study Officials

• Daniel Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Peter Dayan, MD, MSc

  Columbia University

  STUDY DIRECTOR

• Daniel Fenster, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: March 8, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 30, 2019
• Results First Posted: August 21, 2015

Record last verified: 2019-04

Locations

US (1)