Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

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

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-09-30

Brief Summary

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This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.

Detailed Description

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Conditions

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Cleft Palate Repair

Keywords

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codeine phosphate analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Codeine Phosphate Analgesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infants with cleft palate

Minimum Eligible Age

4 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Institute of Child Health

Principal Investigators

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Mike Sury, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute Of Child Health and Great Ormond Street Hospital

Locations

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Great Ormond Street Hospital, Anaesthetics

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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02AR53

Identifier Type: -

Identifier Source: org_study_id