Intravenous and Topical Analgesics for Procedural Pain in Neonates

This study has been completed.

First Received: September 13, 2005 Last Updated: October 10, 2006 History of Changes

Sponsor:	The Hospital for Sick Children
Collaborator:	Canadian Society of Hospital Pharmacists
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00213200

Purpose

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.

Condition	Intervention	Phase
Pain Infant, Newborn	Drug: morphine, amethocaine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Viractin Tetracaine

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	108
Study Start Date:	July 2003
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	up to 30 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Exclusion Criteria:

seizures
receiving muscle relaxants
skin disorders causing disruption of stratum corneum

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213200

Locations

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Society of Hospital Pharmacists

Investigators

Principal Investigator:

Anna Taddio, PhD

The Hospital for Sick Children, Toronto Canada

More Information

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.

Study ID Numbers:	0019990251
Study First Received:	September 13, 2005
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00213200 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

pain
analgesia
morphine
amethocaine
neonate

Additional relevant MeSH terms:

Morphine
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions

Tetracaine
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009