Using Sugar Water to Relieve Pain in Infants

NCT ID: NCT00213213

Last Updated: 2010-03-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-07-31

Brief Summary

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This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.

Detailed Description

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Conditions

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Pain Infant, Newborn Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sucrose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy newborn infants ≥36 weeks gestation
* infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes

Exclusion Criteria

* Admission to the neonatal intensive care unit
* plan to undergo circumcision during the study period
* major congenital or neurological anomalies
* clinical diagnosis of birth asphyxia or seizures
* receiving analgesics or sedatives
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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The Hospital for Sick Children

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

Countries

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Canada

References

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Taddio A, Shah V, Hancock R, Smith RW, Stephens D, Atenafu E, Beyene J, Koren G, Stevens B, Katz J. Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures. CMAJ. 2008 Jul 1;179(1):37-43. doi: 10.1503/cmaj.071734.

Reference Type DERIVED
PMID: 18591525 (View on PubMed)

Other Identifiers

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CIHR MCT-63143

Identifier Type: -

Identifier Source: secondary_id

ISRCTN23411530

Identifier Type: -

Identifier Source: secondary_id

1000002771

Identifier Type: -

Identifier Source: org_study_id

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