Siriraj Hospital
Bangkok Noi, Bangkok, 10700, Thailand
NCT Number: NCT07610915
This project aims to develop and test a new questionnaire to measure how well children recover in the post-anaesthesia care unit (PACU). Currently, children in PACU are mainly assessed using discharge readiness criteria, but these do not fully capture the child's recovery experience or overall wellbeing. Participants will be children aged 2-17 years having elective procedures requiring anaesthesia or sedation, and their parents/caregivers where proxy reporting is needed for younger children. The study will be conducted in stages, including interviews to identify important aspects of recovery, expert review of draft questions, testing of question clarity and acceptability, and field testing of the questionnaire in PACU at planned time points during recovery. Clinical information routinely collected as part of care, such as pain scores, nausea vomiting, airway or oxygen events, and length of stay in PACU, will also be examined to assess how well the questionnaire performs. The expected outcome is a child-centred, practical, and reliable PACU recovery measure that can be used in clinical care, quality improvement, and future research.
Trial opening soon.
Get Notified2 year–17 year
All sexes
Observational
Bangkok Noi, Bangkok, 10700, Thailand
This project aims to address an important gap in paediatric postoperative care. Children recovering in the post-anaesthesia care unit (PACU) are commonly assessed using physiologic discharge-readiness criteria, which focus mainly on safety parameters such as consciousness, breathing, circulation, and readiness to leave PACU. Although these measures are essential for clinical decision-making, they do not fully capture the child's actual recovery experience, including symptoms such as pain, nausea or vomiting, distress, discomfort, tiredness, or poor behavioural recovery. As a result, two children may both meet discharge criteria yet have very different quality of recovery.
At present, there is no well-established child-centred questionnaire designed specifically to measure quality of recovery during the immediate PACU period. This project therefore aims to develop and test a new questionnaire that better reflects what matters to children, families, and clinicians during early recovery after anaesthesia and surgery.
The study will include children aged 2-17 years undergoing elective procedures requiring anaesthesia or sedation, with parent/caregiver proxy reporting used where appropriate for younger children. This is a multicentre collaboration. The Siriraj Hospital site will be involved in Step 1, the qualitative item-generation phase, and Step 4, the field-testing / survey administration phase. In Step 1, interviews with children, parents/caregivers, and clinicians will identify the most important aspects of recovery. In Step 4, the questionnaire will be tested in PACU and compared with routinely collected clinical indicators. The expected outcome is a practical, reliable, and child-centred PACU recovery measure for use in clinical care, quality improvement, and future research.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: Perioperative/Periprocedural (Day of surgery)
The primary outcome is the PedsQoR-PACU questionnaire score, a measure of early postoperative recovery in children in the post-anaesthesia care unit (PACU). The questionnaire will be completed either by the child (self-report, where age-appropriate) or by a parent/caregiver (proxy report, where applicable). Higher scores will indicate better quality of recovery.
Time frame: Perioperative/Periprocedural (Day of surgery)
Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha. Higher values indicate greater internal consistency among questionnaire items.
Time frame: Perioperative/Periprocedural (Day of surgery)
Test-retest reliability will be assessed in a subset of participants who complete a repeat assessment at T2b. Reliability will be evaluated using appropriate agreement statistics. Higher values indicate greater stability of repeated scores.
Time frame: Perioperative/Periprocedural (Day of surgery)
Agreement between child self-report and parent proxy report will be assessed when both are available at the same PACU time point. Agreement will be evaluated using appropriate agreement statistics, such as intraclass correlation coefficients or weighted kappa. Higher values indicate better agreement.
Time frame: Perioperative/Periprocedural (Day of surgery)
Construct validity will be examined by assessing associations between PedsQoR-PACU scores and relevant clinical indicators of PACU recovery, such as pain scores, rescue analgesia, postoperative nausea/vomiting, respiratory support, airway events, and PACU length of stay.
Contact information is provided by the study sponsor or research team.
Mahidol University
Other
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Acronym: PedSQoR-PACU
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