NCT00298584

Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection

Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Not accepted

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 infant's 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.

Conditions

• Pain
• Intensive Care, Neonatal

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Suprapubic Aspiration
PROCEDURE	Urethral Catheterization

Timeline

• Start date: 2006-02-01
• First posted: 2006-03-02
• Last updated: 2007-02-23

Locations

2 sites across 1 country: Canada