Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298584
Status:
UNKNOWN
Last Update Posted:
2007-02-23
First Post:
2006-02-28
Brief Title:
Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection Suprapubic Aspiration and Urinary Catheterization
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
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:
The purpose of this study is to determine which of the two procedures commonly used to collect urine percutaneous suprapubic aspiration SPA and urethral catheterization UC is less painful and the success rates and complication rates associated with both methods
Detailed Description:
Infants hospitalized in the NICU undergo numerous invasive and painful procedures Exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae such as altered pain responses and increased sensitivity to pain Taddio 2005 Fifty eligible infants in the NICU will be randomized to undergo urine collection by either suprapubic aspiration SPA or urinary catheterization UC Outcome measures will include pain procedure success and procedure duration Pain will be measured using facial grimacing the infants face will be videotaped for the entire procedure heart rate and oxygen saturation Procedure success will be defined by the collection of about 2mL of urine Falcao 1999 The procedure duration in seconds for the first attempt will be calculated Infants will be monitored during the procedure for adverse events such as apnea bradycardia desaturation emesis increased ventilatory support Results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure
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