Intravenous and Topical Analgesics for Procedural Pain in Neonates

This study has been completed.

Sponsor:

Collaborator:

Canadian Society of Hospital Pharmacists

Information provided by:

The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT00213200

First received: September 13, 2005

Last updated: October 10, 2006

Last verified: September 2005

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates

Resource links provided by NLM:

Drug Information available for: 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 (Child)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.


ClinicalTrials.gov Identifier:	NCT00213200 History of Changes
Other Study ID Numbers:	0019990251
Study First Received:	September 13, 2005
Last Updated:	October 10, 2006

Keywords provided by The Hospital for Sick Children:


pain analgesia morphine amethocaine neonate

Additional relevant MeSH terms:


Morphine Tetracaine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs	Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local Anesthetics

ClinicalTrials.gov processed this record on July 21, 2017

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