Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01549002
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2012-02-02
Brief Title:
Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage ID in Children
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage ID in Children
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doesnt 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 patients 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 patients 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
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 patients 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None