Intravenous and Topical Analgesics for Procedural Pain in Neonates
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Infant, Newborn | Drug: morphine, amethocaine | Phase 3 |
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 |

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

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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

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
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G 1X5 | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Anna Taddio, PhD | The Hospital for Sick Children, Toronto Canada |
ClinicalTrials.gov Identifier: | NCT00213200 |
Other Study ID Numbers: |
0019990251 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | October 11, 2006 |
Last Verified: | September 2005 |
pain analgesia morphine amethocaine neonate |
Morphine Tetracaine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local Anesthetics |