Intravenous and Topical Analgesics for Procedural Pain in Neonates - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 10, 2006

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00213200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- 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

Descriptive Information

Brief Title ^ICMJE

Intravenous and Topical Analgesics for Procedural Pain in Neonates

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain
Infant, Newborn

Intervention ^ICMJE

Drug: morphine, amethocaine

Study Arms / Comparison Groups

Publications *

Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. Erratum in: JAMA. 2006 Apr 5;295(13):1518.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

108

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 30 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00213200

Responsible Party

Study ID Numbers ^ICMJE

0019990251

Study Sponsor ^ICMJE

The Hospital for Sick Children

Collaborators ^ICMJE

Canadian Society of Hospital Pharmacists

Investigators ^ICMJE

Principal Investigator:

Anna Taddio, PhD

The Hospital for Sick Children, Toronto Canada

Information Provided By

The Hospital for Sick Children

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP