RecruitingACTRN12623000379617

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

Investigating Oximetry and Capnography To assess the impact of Opiate Infusions on Patients Undergoing Palatoplasties – a Pilot Study (OCTOPUS)

Sponsor

Perth Children's Hospital

Enrollment

60 participants

Start Date

Jul 18, 2023

Study Type

Interventional

Conditions

Children undergoing general anaesthesia Children undergoing palatoplasty surgery Children receiving opiate infusions

Summary

Cleft palate is a birth defect that affects the roof of the mouth and requires surgery in the first year of life to close the abnormal opening between the nose and mouth. After surgery, moderate to severe pain is managed using opioid painkillers. However, opioids can cause breathing problems and can be especially risky for children who have had cleft palate surgery. Monitoring a patient's oxygen and carbon dioxide levels can help clinicians understand a patient's respiratory status and detect changes in their breathing and ventilation. This is important in patients who are vulnerable to breathing problems, such as patients recovering after cleft palate surgery. Carbon dioxide monitoring is not currently a routine feature of monitoring for palatoplasty patients. A proposed pilot study aims to monitor both oxygen and carbon dioxide saturations in infants on opioid infusions after palatoplasty to better understand their ventilatory recovery after cleft palate surgery.

Eligibility

Sex: Both males and femalesMax Age: 18 Monthss

Plain Language Summary

Simplified for easier understanding

Cleft palate is a birth defect where the roof of the mouth does not close properly during foetal development, creating an opening between the mouth and nasal cavity. Surgical repair is performed in the first year of life, and after the operation, babies need pain relief — typically opioid medications (strong painkillers like morphine) given through a drip. However, opioids can suppress breathing, and this risk is particularly significant in young infants, especially those who were born prematurely. This pilot study is monitoring oxygen and carbon dioxide levels in infants before and after cleft palate surgery using two types of non-invasive sensors — a standard pulse oximeter and a transcutaneous carbon dioxide monitor placed gently on the skin. The goal is to understand how babies' breathing is affected during the recovery period and to identify which infants may need closer monitoring, laying the groundwork for a larger study. Your baby may be eligible if they are under 18 months of age and are scheduled to have cleft palate repair surgery at Perth Children's Hospital, with a plan for post-operative opioid pain management. Babies with known heart or lung conditions, or those who will need to remain on a breathing tube after surgery, would not be eligible.

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Interventions

A single-centre pilot study will be carried out at Perth Children’s Hospital in Western Australia. Once voluntary informed consent is obtained, the participant will be issued with a Nonin WristOx pulse oximeter, and all required batteries and fixumol tape, for the participant to wear for at least 8 hours on three consecutive nights, along with a diary to record the times for which the device was worn. The Nonin WristOx 3150 is a small, lightweight pulse oximeter designed to be worn comfortably on the patient’s wrist or ankle and is ideal for use in the patient’s home (WristOx 3150, Nonin Medical, Plymouth, MN). Pre-operative monitoring will be completed within 8 weeks of the patient’s surgery date. On the day of surgery relevant information on the patient’s demographics and medical history will be collected. Parents will be asked to complete a brief questionnaire on their child’s sleeping habits pre-operatively. Continuous monitoring of oxygen will commence within an hour of the patient being connected to their post-operative opiate infusion. Oximetry data will be obtained using the same Nonin WristOx 3150. Transcutaneous CO2 (tcCO2) will be measured overnight using the SenTec digital monitoring system (SenTec, Lincoln, RI 02685 United States) using a probe connected to the patient’s forehead or shoulder. TcCO2 sensors will be connected within two hours of the patient’s normal bedtime, on the night of surgery. Both sensors will be removed 12 hours after the tcCO2 sensor is placed. These post-operative measurements will be performed in addition to standard ward monitoring.

Locations(1)

Perth Children's Hospital - Nedlands

WA, Australia

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ACTRN12623000379617