Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates

The Hospital for Sick Children2 sites in 1 country108 target enrollmentJuly 2003

ConditionsPain Infant, Newborn

Drugsmorphine, amethocaine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pain
Sponsor: The Hospital for Sick Children
Enrollment: 108
Locations: 2
Primary Endpoint: - Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

June 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

•preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
•ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)