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

NCT ID: NCT01549002

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intranasal Fentanyl

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Morphine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Intravenous Morphine

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

Intervention Type: DRUG

Other Intervention Names

Fentanyl; Morphine

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S Tsze, MD, MPH

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Tsze, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Peter Dayan, MD, MSc

Role: STUDY_DIRECTOR

Columbia University

Daniel Fenster, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27387971 (View on PubMed)

Related Links

http://www.intranasal.net/

Educational portal for therapeutic intranasal drug delivery

Other Identifiers

AAAI0699

Identifier Type: -

Identifier Source: org_study_id