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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00298584
First received: February 28, 2006
Last updated: February 22, 2007
Last verified: August 2006

February 28, 2006
February 22, 2007
February 2006
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infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
- Infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
Complete list of historical versions of study NCT00298584 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
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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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
  • Pain
  • Intensive Care, Neonatal
  • Procedure: Percutaneous Suprapubic Aspiration
  • Procedure: Urethral Catheterization
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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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
Both
up to 6 Months
No
Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@sickkids.ca
Canada
 
NCT00298584
1000008396
Not Provided
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The Hospital for Sick Children
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Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP