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OpenTrials
Completed

NCT Number: NCT00213200

Intravenous and Topical Analgesics for Procedural Pain in Neonates

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.

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Key information

Conditions

Pain Agnosia Infant, Newborn Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

morphine, amethocaine

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Society of Hospital Pharmacists

Registry information

Official study title

Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates

Important dates

Study start
2003
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Oct 11, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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