Intravenous and Topical Analgesics for Procedural Pain in Neonates

NCT00213200 | Completed Phase 3

• 1 other identifier: 0019990251
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Infant, Newborn

Keywords

pain; analgesia; morphine; amethocaine; neonate

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

morphine, amethocaine DRUG

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• seizures
• receiving muscle relaxants
• skin disorders causing disruption of stratum corneum

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Society of Hospital Pharmacists: collaborator

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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. doi: 10.1001/jama.295.7.793.

  PMID: 16478902 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Morphine; Tetracaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Anna Taddio, PhD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2003
• Study Completion: June 1, 2005
• Last Updated: October 11, 2006

Record last verified: 2005-09

Locations

CA (2)