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Intravenous and Topical Analgesics for Procedural Pain in Neonates

This study has been completed.
Canadian Society of Hospital Pharmacists
Information provided by:
The Hospital for Sick Children Identifier:
First received: September 13, 2005
Last updated: October 10, 2006
Last verified: September 2005
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
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:

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

Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00213200

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
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
  More Information

Publications: 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:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics processed this record on May 25, 2017