A pilot study measuring Oxygen and Carbon Dioxide in order to assess the impact of Opiate Infusions on young children Undergoing Palatoplasties

Not Applicable

Recruiting

• Conditions: Children undergoing palatoplasty surgery; Children receiving opiate infusions; Children undergoing general anaesthesia; Anaesthesiology - Anaesthetics; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery

• Registration Number: ACTRN12623000379617
• Lead Sponsor: Perth Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients aged 0 to 18 months undergoing cleft palate repair under general anaesthesia who will be receiving a post-operative opiate infusion.

Exclusion Criteria

Children with known significant cardiopulmonary disease.
Children currently taking opioid medications.
Children going intubated to the HDU/ICU post-operatively.
Children who will be unable to complete at-home oximetry pre-operatively.
Inability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the rate of successful participant recruitment as determined by an audit of study screening logs and enrollment logs at the completion of recruitment. [ From beginning of study until end of recruitment.];To assess the rate of adherence to the protocol without deviation as determined by a review of the medical records. [ From participant enrollement until end of participation.];To assess the viability of the assessment of overnight oxygenation and ventilation in infants post-palatoplasty from review of all evaluable data from the equipment. Evaluable data is defined as a minimum of 4 hours of good quality monitoring data. [ The quality of the measurements will be assessed following every patient until the recruitment target is met.]