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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
  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
Endpoint Classification: Safety/Efficacy Study
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:


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

Keywords provided by The Hospital for Sick Children:
pain
analgesia
morphine
amethocaine
neonate

Additional relevant MeSH terms:
Morphine
Tetracaine
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014