Postoperative Recovery in ChildrenPedSQoR-PACUNCT07610915
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit
An observational study of Postoperative Recovery in Children, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Postoperative Recovery in Children
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jun 2026to 31 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include children aged 2-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation at Siriraj Hospital, and their parents/caregivers where proxy reporting is applicable. Children aged 8-17 years may provide self-report data, while parents/caregivers may provide proxy-report data for younger children and participate in qualitative interviews where relevant.
Who may be able to join
- Children aged 8-17 years for self-report version
- Parents/caregivers of children aged 2-7 years for proxy-report version
- Elective surgery/procedure under anaesthesia
- Planned recovery in PACU
- ASA I-IV
- Able to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
Show all 12Show fewer
- Informed consent/assent obtained as applicable Exclusion criteria
- Unable to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
- Urgent or emergency surgery/procedure
- Not planned to recover in PACU, including planned direct transfer from theatre to ICU
- Developmental delay or other condition limiting comprehension for interview participation or questionnaire completion
- Not available for an uninterrupted interview or questionnaire completion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Issada Jindawatthana, MD., 0624196194, issada.j@mahidol.ac.th
About this study
Official title: Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
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.
Read the detailed description
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.
- Conditions
- Postoperative Recovery in Children
- Keywords
- Pediatric anesthesia, Postoperative recovery, Patient-reported outcomes, Questionnaire development, Questionnaire validation, Psychometric validation, postanesthesia-care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children aged 8-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation. Participants will complete study assessments relating to early recovery in the post-anaesthesia care unit (PACU). This is an observational study and no intervention is assigned. | |
| Parent/caregiver | Parents or primary caregivers of participating children, or of children aged 2-7 years where proxy reporting is required. Participants will provide proxy-reported assessments about their child early recovery phase. This is an observational study and no intervention is assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQoR-PACU questionnaire score
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.
Measured: Perioperative/Periprocedural (Day of surgery)
Secondary outcomes (4)
Internal consistency of the PedsQoR-PACU questionnaire
Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha. Higher values indicate greater internal consistency among questionnaire items.
Measured: Perioperative/Periprocedural (Day of surgery)
Test-retest reliability of the PedsQoR-PACU questionnaire
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.
Measured: Perioperative/Periprocedural (Day of surgery)
Child-parent agreement for the PedsQoR-PACU questionnaire score
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.
Measured: Perioperative/Periprocedural (Day of surgery)
Construct validity of the PedsQoR-PACU questionnaire score
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.
Measured: Perioperative/Periprocedural (Day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start21 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Recovery in ChildrenStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Murdoch Childrens Research Institute
- Responsible party
- Principal investigator, Issada Jindawatthana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610915
- Sponsor's protocol ID
- Si 594/2026
- Acronym
- PedSQoR-PACU
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
- ClinicalTrials.gov ID
- NCT07610915
- Acronym / sponsor ID
- PedSQoR-PACU / Si 594/2026
- Conditions
- Postoperative Recovery in Children
- Keywords
- Pediatric anesthesia, Postoperative recovery, Patient-reported outcomes, Questionnaire development, Questionnaire validation, Psychometric validation, postanesthesia-care unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Murdoch Childrens Research Institute
- Study start
- 21 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children aged 8-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation. Participants will complete study assessments relating to early recovery in the post-anaesthesia care unit (PACU). This is an observational study and no intervention is assigned. |
| Parent/caregiver | – | –Parents or primary caregivers of participating children, or of children aged 2-7 years where proxy reporting is required. Participants will provide proxy-reported assessments about their child early recovery phase. This is an observational study and no intervention is assigned. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include children aged 2-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation at Siriraj Hospital, and their parents/caregivers where proxy reporting is applicable. Children aged 8-17 years may provide self-report data, while parents/caregivers may provide proxy-report data for younger children and participate in qualitative interviews where relevant.
Key inclusion criteria (12 listed)
- Children aged 8-17 years for self-report version
- Parents/caregivers of children aged 2-7 years for proxy-report version
- Elective surgery/procedure under anaesthesia
- Planned recovery in PACU
- ASA I-IV
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PedsQoR-PACU questionnaire score
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.
4 secondary outcomes
Internal consistency of the PedsQoR-PACU questionnaire
Time frame: Perioperative/Periprocedural (Day of surgery)
Test-retest reliability of the PedsQoR-PACU questionnaire
Time frame: Perioperative/Periprocedural (Day of surgery)
Child-parent agreement for the PedsQoR-PACU questionnaire score
Time frame: Perioperative/Periprocedural (Day of surgery)
Construct validity of the PedsQoR-PACU questionnaire score
Time frame: Perioperative/Periprocedural (Day of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Recovery in Children
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
Remifentanil vs Fentanyl in Children 7-12 After Urologic Surgery: Emergence Delirium and Recovery Quality
Emergence Delirium, Emergence Agitation
RecruitingPhase 4
Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
MRI Sedation, Pediatric Sedation
Not yet recruitingPhase 4
Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)
Postoperative Sleep Quality, Postoperative Behaviour
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Recovery in Children, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Issada Jindawatthana, MD. (+66624196194, issada.j@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PedsQoR-PACU questionnaire score (time frame: Perioperative/Periprocedural (Day of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.