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Intravenous and Topical Analgesics for Procedural Pain in Neonates

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ClinicalTrials.gov Identifier: NCT00213200
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 11, 2006
Sponsor:
Collaborator:
Canadian Society of Hospital Pharmacists
Information provided by:
The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date October 11, 2006
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00213200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous and Topical Analgesics for Procedural Pain in Neonates
Official Title  ICMJE Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Infant, Newborn
Intervention  ICMJE Drug: morphine, amethocaine
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
108
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00213200
Other Study ID Numbers  ICMJE 0019990251
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Canadian Society of Hospital Pharmacists
Investigators  ICMJE
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
PRS Account The Hospital for Sick Children
Verification Date September 2005

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