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Intravenous and Topical Analgesics for Procedural Pain in Neonates

NCT ID: NCT00213200

Last Updated: 2006-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Pain Infant, Newborn

Keywords

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pain analgesia morphine amethocaine neonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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morphine, amethocaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Society of Hospital Pharmacists

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Principal Investigators

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Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 16478902 (View on PubMed)

Other Identifiers

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0019990251

Identifier Type: -

Identifier Source: org_study_id