ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous and Topical Analgesics for Procedural Pain in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213200
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 11, 2006
Sponsor:
Collaborator:
Canadian Society of Hospital Pharmacists
Information provided by:
The Hospital for Sick Children

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pain Infant, Newborn Drug: morphine, amethocaine Phase 3

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
Study Start Date : July 2003
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tetracaine
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. - Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups

Secondary Outcome Measures :
  1. heart rate at the time of procedure
  2. oxygen saturation at the time of procedure
  3. local skin reactions at the time of procedure
  4. blood pressure for 24 hours post procedure
  5. ventilatory support for 24 hours post procedure

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00213200     History of Changes
Other Study ID Numbers: 0019990251
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: September 2005

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