Intravenous and Topical Analgesics for Procedural Pain in Neonates

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213200
• Other study ID #: 0019990251
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 10, 2006
• Start date: July 2003
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Newborn
• Pain

Intervention

Drug:
• morphine, amethocaine

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Society of Hospital Pharmacists

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Secondary	heart rate at the time of procedure
Secondary	oxygen saturation at the time of procedure
Secondary	local skin reactions at the time of procedure
Secondary	blood pressure for 24 hours post procedure
Secondary	ventilatory support for 24 hours post procedure