Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Pain Intensive Care, Neonatal |
Procedure: Percutaneous Suprapubic Aspiration Procedure: Urethral Catheterization |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization |
- infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
- 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
| 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.
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00298584 History of Changes |
| Other Study ID Numbers: | 1000008396 |
| Study First Received: | February 28, 2006 |
| Last Updated: | February 22, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
Diagnostic techniques, urological urinary catheterization Aspiration Neonates |
Neonatal Intensive Care Unit Infant, Newborn Infant, Premature Infant, Low-birth weight |
ClinicalTrials.gov processed this record on May 19, 2013