Intravenous and Topical Analgesics for Procedural Pain in Neonates

Phase 3

Completed

• Conditions: Pain; Infant, Newborn

• Registration Number: NCT00213200
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2006-10-10
• Last Update Posted: 2006-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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)

Exclusion Criteria

• seizures
• receiving muscle relaxants
• skin disorders causing disruption of stratum corneum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups

Secondary Outcome Measures

Name	Time	Method
heart rate at the time of procedure
oxygen saturation at the time of procedure
local skin reactions at the time of procedure
blood pressure for 24 hours post procedure
ventilatory support for 24 hours post procedure

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada