Clinical trial NCT00298584: Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection
Official title: Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain
Intensive Care, Neonatal
Keywords: Diagnostic techniques, urological
urinary catheterization
Aspiration
Neonates
Neonatal Intensive Care Unit
Infant, Newborn
Infant, Premature
Infant, Low-birth weight
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
Secondary outcomes:
measure: success rate of obtaining a sample suitable for analysis
measure: adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
measure: success rate of procedure according to infant factors; gestational age and sex
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Naggar W, Yiu A, Mohamed A, Shah V, Manley J, McNamara P, Taddio A. Comparison of pain during two methods of urine collection in preterm infants. Pediatrics. 2010 Jun;125(6):1224-9. doi: 10.1542/peds.2009-3284. Epub 2010 May 17.