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Trial NCT00519207

Resource URI: http://static.linkedct.org/resource/trials/NCT00519207
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/11652>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/22586>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/26751>
linkedct:brief_title Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/9528>
linkedct:criteria Inclusion Criteria: - Healthy newborn infants -  37 weeks gestational age. Exclusion Criteria: - neonatal intensive care unit (NICU) admission - asphyxia, seizures - major birth defect (heart, brain, genetic syndrome) - circumcised during study - receiving analgesia/sedatives.
linkedct:description Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large. This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 7 Days
linkedct:eligibility_minimum_age N/A
linkedct:end_date June 2009
linkedct:enrollment 330 (xsd:int)
linkedct:firstreceived_date August 20, 2007
linkedct:has_dmc Yes
linkedct:id NCT00519207
linkedct:intervention <http://static.linkedct.org/resource/intervention/24617>
linkedct:intervention <http://static.linkedct.org/resource/intervention/26271>
rdfs:label Trial NCT00519207
linkedct:lastchanged_date May 22, 2008
linkedct:lead_sponsor_agency The Hospital for Sick Children
linkedct:location <http://static.linkedct.org/resource/location/20398>
linkedct:location <http://static.linkedct.org/resource/location/20428>
linkedct:nct_id NCT00519207
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial
linkedct:org_study_id 1000010747
linkedct:overall_contact_email anna.taddio@sickkids.ca
linkedct:overall_contact_last_name Anna Taddio, PhD
linkedct:overall_contact_phone 416-813-6235
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/3377>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00519207>
linkedct:phase Phase 3
linkedct:primary_completion_date February 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/62552>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/132267>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/32522>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/41965>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/51165>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/61551>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/70758>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/88399>
linkedct:source The Hospital for Sick Children
linkedct:start_date August 2007
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.
rdf:type linkedct:trials
linkedct:verification_date February 2008