NCT00386269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

October 10, 2006

Last Update Submit

November 28, 2007

Conditions

Cleft Palate Repair

Keywords

codeine phosphate analgesia

Outcome Measures

Primary Outcomes (1)

  • Dose of morphine used within the first 6h after surgery

Secondary Outcomes (1)

  • Pain scores

Interventions

Codeine Phosphate AnalgesiaDRUG

Eligibility Criteria

Age4 Months - 8 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants with cleft palate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital, Anaesthetics

London, WC1N 1EH, United Kingdom

Location

Study Officials

  • Mike Sury, Dr

    Institute Of Child Health and Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

January 1, 2004

Study Completion

September 1, 2007

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

GB(1)