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

September 13, 2005
October 10, 2006
July 2003
Not Provided
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Same as current
Complete list of historical versions of study NCT00213200 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
Intravenous and Topical Analgesics for Procedural Pain in Neonates
Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pain
  • Infant, Newborn
Drug: morphine, amethocaine
Not Provided
Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. Erratum in: JAMA. 2006 Apr 5;295(13):1518.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2005
Not Provided

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
Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00213200
0019990251
Not Provided
Not Provided
The Hospital for Sick Children
Canadian Society of Hospital Pharmacists
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP