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

The Hospital for Sick Children

Status and phase

Unknown

Phase 3

Conditions

Intensive Care, Neonatal

Pain

Treatments

Procedure: Percutaneous Suprapubic Aspiration

Procedure: Urethral Catheterization

Study type

Interventional

Funder types

Other

Identifiers

NCT00298584

1000008396

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 day to 6 months old

Volunteers

No Healthy Volunteers

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