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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00298584
• Other study ID #: 1000008396
• Status: Recruiting
• Phase: Phase 3
• First received: February 28, 2006
• Last updated: February 22, 2007
• Start date: February 2006

Study information

• Verified date: August 2006
• Source: The Hospital for Sick Children
• Contact: Anna Taddio, PhD
• Phone: 416-813-6235
• Email: anna.taddio[@]sickkids.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intensive Care, Neonatal
• Pain

Intervention

Procedure:
• Percutaneous Suprapubic Aspiration

• Urethral Catheterization

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
Secondary	success rate of obtaining a sample suitable for analysis
Secondary	adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
Secondary	success rate of procedure according to infant factors; gestational age and sex