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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00298584 |
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.
Condition | Intervention | Phase |
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Pain Intensive Care, Neonatal |
Procedure: Percutaneous Suprapubic Aspiration Procedure: Urethral Catheterization |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization |
Estimated Enrollment: | 50 |
Study Start Date: | February 2006 |
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.
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Taddio, PhD | 416-813-6235 | anna.taddio@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@sickkids.ca | |
Principal Investigator: Anna Taddio, PhD | |
Sub-Investigator: Patrick McNamara, MD | |
Sub-Investigator: Walid El Naggar, MD | |
Sub-Investigator: Jennifer Manley, BA | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Contact: Vibhuti Shah, MD 416-586-4800 ext 4816 vshah@mtsinai.on.ca | |
Principal Investigator: Vibhuti Shah, MD |
Principal Investigator: | Anna Taddio, PhD | The Hospital for Sick Children, Toronto Canada |
Study ID Numbers: | 1000008396 |
Study First Received: | February 28, 2006 |
Last Updated: | February 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00298584 |
Health Authority: | Canada: Ethics Review Committee |
Diagnostic techniques, urological urinary catheterization Aspiration Neonates |
Neonatal Intensive Care Unit Infant, Newborn Infant, Premature Infant, Low-birth weight |
Body Weight Birth Weight Pain |