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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386269

Enrollment

Registered

2006-10-11

Start date

2004-01-31

Completion date

2007-09-30

Last updated

2007-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate Repair

Keywords

codeine phosphate analgesia

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.

Interventions

DRUGCodeine Phosphate Analgesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

4 Months to 8 Months

Healthy volunteers

Yes

Inclusion criteria

* Infants with cleft palate

Design outcomes

Primary

Measure	Time frame
Dose of morphine used within the first 6h after surgery	—

Secondary

Measure	Time frame
Pain scores	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026