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

Phase 3

• Conditions: Pain; Intensive Care, Neonatal

• Registration Number: NCT00298584
• Lead Sponsor: The Hospital for Sick Children

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 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study First Posted: 2006-03-02
• Status Verified: 2006-08
• Last Update Submitted: 2007-02-22
• Last Update Posted: 2007-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis

Exclusion Criteria

• Clinical diagnosis of birth asphyxia or seizures
• Neurological conditions
• Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
• Abdominal distension or abdominal infection/cellulitis
• Colostomy
• Inguinal hernia
• Organomegaly
• Bleeding diatheses (thrombocytopenia or coagulopathy)
• Receiving analgesics or sedatives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure

Secondary Outcome Measures

Name	Time	Method
success rate of obtaining a sample suitable for analysis
adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
success rate of procedure according to infant factors; gestational age and sex

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada