Intravenous and Topical Analgesics for Procedural Pain in Neonates - Full Text View

Intravenous and Topical Analgesics for Procedural Pain in Neonates

This study has been completed.

Sponsors and Collaborators:	The Hospital for Sick Children 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

MedlinePlus related topics:

Anesthesia

Drug Information available for:

Tetracaine Viractin

U.S. FDA Resources

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

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 of Results:

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
First Received:	September 13, 2005
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00213200
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

pain

analgesia

morphine

amethocaine

neonate

Study placed in the following topic categories:

Tetracaine

Morphine

Pain

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Narcotics

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

Pharmacologic Actions

Anesthetics, Local

ClinicalTrials.gov processed this record on November 30, 2008