Postoperative Sleep QualityPhase 4SCORPIONNCT07777276
Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)
A Phase 4 study testing Dexamethasone (IV) and Ondansetron iv in people with Postoperative Sleep Quality and Postoperative Behaviour, run by Telethon Kids Institute at 3 sites in 2 countries.
Trial summary
Nausea and vomiting are common complications after anaesthesia, and anaesthetists routinely give medications to prevent them. Dexamethasone and ondansetron are the two most commonly used agents and have a long safety record. However, their effects on sleep, behaviour, and overall recovery are not well studied. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Postoperative Sleep Quality, Postoperative Behaviour, Postoperative Recovery in Children
- What is being tested?
- Dexamethasone (IV) and Ondansetron iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Aug 2026to 17 Aug 2029
- Phase
- Phase 4
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 - 15 years,
- Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively
- ASA I or III
Who cannot join
- Currently taking regular dexamethasone or ondansetron
- Currently taking regular steroids, including inhaled corticosteroids
- Anaesthetic plan to give dual PONV prophylaxis
- Known hypersensitivity to the active substance or to any of the excipients listed
- Language barriers impeding data collection
- Department for Child Protection and Family Support is involved in their care
Show all 11Show fewer
- Planned admissions to the Paediatric Intensive Care Unit (PICU)
- Oncology patients
- Severe developmental delay
- ASA III or above
- Significant cardiorespiratory conditions
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Brazil2 sites
Hospital das Clinicas
São Paulo, São Paulo
Vinícius Quintão, MD, PhD, +55 11 2661 5795, vinicius.quintao@hc.fm.usp.br
Vinícius Quintão, MD PHD
Santa Casa de Misericórdia de Ribeirão Preto
São Paulo, São Paulo
Ricardo Vieira Carlos, MD, +55 11 2661 5795, ricardovieirac@gmail.com
Ricardo Vieira Carlos, MD
Australia1 site
Perth Children's Hospital
Perth, Western Australia, 6009
Britta S von Ungern-Sternberg, MD, PhD, +61864564806, britta.regli-vonungern@health.wa.gov.au
Lliana Slevin, Bsc, +61 864564806, lliana.slevin@health.wa.gov.au
About this study
Official title: Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting
Nausea and vomiting are common complications after anaesthesia, and anaesthetists routinely give medications to prevent them. Dexamethasone and ondansetron are the two most commonly used agents and have a long safety record. However, their effects on sleep, behaviour, and overall recovery are not well studied. Understanding these will guide future care. The aim of this study is to determine if dexamethasone or ondansetron given during an anaesthetic affect post-operative sleep, behaviour and recovery in children.
Patients enrolled in the study will be randomised to receive either dexamethasone or ondansetron during their procedure. This randomisation will be blinded to patients, their families and their treating anaesthetist. Information about the patient's pain, recovery and sleep will be collected over 7 days post-operatively using online surveys.
A subset of patients will also be asked to complete additional pre-operative non-invasive monitoring using an oximeter and an actigraph to measure their sleep quality before and after surgery. In addition to the postoperative surveys, these patients will be asked to wear the oximeter and actigraph for 3 nights before and immediatey after surgery. Patients who are admitted overnight postoperatively will also have additional transcutaneous carbon dioxide monitoring on the night of their surgery.
Read the detailed description
Postoperative nausea and vomiting (PONV) are a common complication after anaesthesia. Therefore, it is standard practice to administer either ondansetron and/or dexamethasone intraoperatively as prophylaxis. PONV affects up to 30-40% of the general surgical population and up to 80% of high-risk patients, making it one of the most distressing complications of the perioperative period.Uncontrolled PONV prolongs recovery room stay, increases unplanned hospital re-admissions, and is consistently identified by patients and families as one of the most undesirable aspects of the surgical experience. It was ranked in the top 10 research priorities in perioperative medicine in a recent large consumer engagement study involving over 350 children.
Ondansetron, a 5-HT3 receptor antagonist, and dexamethasone, a corticosteroid, are the two most widely used agents for PONV prophylaxis in paediatric anaesthesia, often administered in combination.Dexamethasone exerts well-documented glucocorticoid effects, including modulation of the hypothalamic-pituitary-adrenal (HPA) axis, suppression of endogenous cortisol secretion, and direct actions on brain structures involved in arousal and sleep regulation, including the hippocampus, hypothalamus, and limbic system.a single intraoperative dose of dexamethasone (0.1-0.5 mg/kg) has been shown to produce measurable HPA axis suppression lasting 24-48 hours postoperatively in children, as well as transient elevations in blood glucose and behavioural changes including hyperactivity, irritability, and emotional lability.
Sleep is a critical component of paediatric postoperative recovery. Disrupted postoperative sleep has been associated with increased pain perception, impaired immune function, heightened parental anxiety, and prolonged behavioural disturbance following surgery. Glucocorticoids are known to disrupt sleep architecture, including fragmentation of sleep, suppression of slow-wave sleep, and reductions in total sleep time. In children, the effects of a single perioperative dose of dexamethasone on sleep remain poorly characterised. In contrast, ondansetron does not directly affect the HPA axis or glucocorticoid receptors, and its central effects are limited primarily to 5-HT3 receptor blockade, with no established direct mechanism for sleep disruption. Postoperative negative behavioural changes (PNBC) in children, sometimes referred to as "new-onset behavioural problems", are a recognised sequela of paediatric anaesthesia and surgery, affecting up to 54% of children in the first 2 weeks following surgery. The potential role of perioperative dexamethasone in exacerbating these changes through glucocorticoid-mediated effects on the developing brain has not been systematically examined. Understanding whether the choice of PONV prophylaxis agent influences postoperative sleep quality and behaviour could have important implications for anaesthetic practice and family-centred postoperative care.
This study aims to investigate the impact of intraoperative intravenous dexamethasone vs ondansetron administered for prophylaxis of postoperative nausea and vomiting (PONV) on postoperative sleep, behaviour and recovery in children undergoing general anaesthesia.
- Conditions
- Postoperative Sleep Quality, Postoperative Behaviour, Postoperative Recovery in Children, Postoperative Nausea and Vomiting (PONV), Paediatric Surgery, Anaesthesia
- Being tested
- Dexamethasone (IV), Ondansetron iv
- Keywords
- paediatric, surgery, postoperative nausea and vomiting, paediatric anaesthesia, sleep quality, postoperative recovery
- Medical subject headings
- Postoperative Nausea and Vomiting, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Dexamethasone (0.2 mg/kg, maximum 8 mg) will be diluted to 2mL with normal saline and administered intravenously at the start of procedure.
Ondansetron ivDrug
Ondansetron (0.15mg/kg, maximum 4mg) will be diluted to 2mL with normal saline and administered intravenously 15-30 minutes before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Active comparator | Dexamethasone will be sourced from the hospital pharmacy as standard registered medications. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. Dexamethasone will be administered intravenously at 0.2 mg/kg (maximum 8 mg) at the start of procedure.The patient-specific dose of the investigational product will be diluted to 2ml with normal saline to ensure blinding of the anaesthetist in charge of the patient. The trial will mimic this institutional standard practice by providing two syringes to every treating anaesthetist. The first syringe will contain the patient's dose of dexamethasone diluted to 2mL, the second syringe will contain 2mL of normal saline. Receives: Drug: Dexamethasone (IV) |
| Ondansetron Group | Active comparator | Ondansetron will be administered intravenously at 0.15 mg/kg (maximum 4 mg) 15-30 min before the end of surgery. The dose will be diluted to 2ml with normal saline to ensure blinding by the anaesthetist. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. The first syringe will contain 2mL of normal saline, the second syringe will contain the patient's dose of ondansetron diluted to 2mL. Receives: Drug: Ondansetron iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Parent-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Measured: Sleep quality will be assessed on day 1 post-surgery
Secondary outcomes (11)
Compare parent-reported sleep quality preoperatively and on postoperative days 2,3,5 and 7 between children who received dexamethasone and children who received ondansetron intraoperatively.
Sleep quality is measured on a 0 -10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Measured: Parent-reported preoperative sleep quality will be collected on the day of surgery and postoperatively on days 2,3,5 and 7.
Compare child-reported (if child is aged over 8 years) sleep quality on postoperative days 1, 2, and 7 between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Child reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep
Measured: child reported sleep quality will be measure don days 1, 2, and 7 postoperatively
Compare parent reported postoperative recovery on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Postoperative recovery will be measured using the Pediatric Scale for Quality of Recovery (PedSQoR). The overall score will range from 20 to 100, higher scores indicate a better quality of recovery or a more complete recovery.
Measured: Postoperative recovery will be measured postoperative days 1, 2, 3, 5, and 7
Compare parent reported postoperative behaviour on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Postoperative behaviour will be measured using the the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS). The scores range from 11 - 55. Higher scores indicate increased behavioural changes post-surgery,
Measured: postoperative behaviour will be measured on postoperative days 1, 2, 3, 5, and 7
Compare parent reported average and maximum pain score on postoperative days 1, 2, 3, 5, and 7 or until the child has returned to normal function between children in the dexamethasone group and children in the ondasetron group
Parent reported post-operative pain will be measured using the Verbal Rating Scale 0 - 10 [VRS] where 0 is no pain and 10 is the worst possible pain.
Measured: postoperative pain will be measured on days 1, 2, 3, 5 and 7 or until the child returns to normal function.
Comparison of sleep disturbances at baseline and 7 days post-surgery between children in the dexamethasone group and children in the ondasetron group
Sleep disturbance will be measured using the Patient Reported Outcomes Information System (PROMIS) Parent Proxy Sleep Disturbance - Short Form 8a. Higher scores indicate more severe sleep disturbances as reported by the parent
Measured: Sleep disturbance will be measured at baseline on the day of surgery in the pre-operative holding area and on postoperative day 7
Comparison of the incidence of early postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group
Postoperative nausea and vomiting will as self-reported by the patient or parent reported
Measured: From PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first.
Comparison of the use of rescue medication for postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group
Rescue medications given will be as recorded on the patient's medication chart
Measured: from PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first
Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative recovery
postoperative recovery will be measured using the Pediatric Scale for Quality of Recovery (PedSQoR)
Measured: STUBR questionnaire will be administered preoperatively and recovery will be assessed on postoperative days 1,2,3,5, and 7
Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative sleep
Parent-reported and child-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Measured: Parent reported sleep quality will be measured on postopeative days 1,2,3,5, and 7. Child reported sleep quality (if the child is older than 8 years) will be measured on postoperative days 1,2, and 7.
Impact of sedative premedication on postoperative delirium
Emergence delirium will be assessed by the post-operative recovery nurse using the WATCHA Scale. The WATCHA Scale is scored from 0 (asleep) to 4 (thrashing around). Scores greater than or equal to 2 on this scale are indicative of emergence delirium.
Measured: Delirium will be assessed from PACU arrival until PACU discharge criteria met
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion17 Aug 2029 (estimated)
- Study completion17 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep QualityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a mulitcentre double-blinded, randomised, controlled pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital, Santa Casa de Misericórdia de Ribeirão Preto, Child and Adolescent Health Service - Perth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777276
- Sponsor's protocol ID
- RGS0000008604
- Acronym
- SCORPION
- Status last verified
- May 2026
- First submitted
- 23 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07777276
- Acronym / sponsor ID
- SCORPION / RGS0000008604
- Conditions
- Postoperative Sleep Quality, Postoperative Behaviour, Postoperative Recovery in Children, Postoperative Nausea and Vomiting (PONV), Paediatric Surgery, Anaesthesia
- Keywords
- paediatric, surgery, postoperative nausea and vomiting, paediatric anaesthesia, sleep quality, postoperative recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital, Santa Casa de Misericórdia de Ribeirão Preto, Child and Adolescent Health Service - Perth
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 17 Aug 2029 (estimated)
- Study completion
- 17 Aug 2029 (estimated)
- First posted
- 20 Aug 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.
Nausea and vomiting are common complications after anaesthesia, and anaesthetists routinely give medications to prevent them. Dexamethasone and ondansetron are the two most commonly used agents and have a long safety record. However, their effects on sleep, behaviour, and overall recovery are not well studied. Understanding these will guide future care. The aim of this study is to determine if dexamethasone or ondansetron given during an anaesthetic affect post-operative sleep, behaviour and recovery in children.
Patients enrolled in the study will be randomised to receive either dexamethasone or ondansetron during their procedure. This randomisation will be blinded to patients, their families and their treating anaesthetist. Information about the patient's pain, recovery and sleep will be collected over 7 days post-operatively using online surveys.
A subset of patients will also be asked to complete additional pre-operative non-invasive monitoring using an oximeter and an actigraph to measure their sleep quality before and after surgery. In addition to the postoperative surveys, these patients will be asked to wear the oximeter and actigraph for 3 nights before and immediatey after surgery. Patients who are admitted overnight postoperatively will also have additional transcutaneous carbon dioxide monitoring on the night of their surgery.
Detailed description
Postoperative nausea and vomiting (PONV) are a common complication after anaesthesia. Therefore, it is standard practice to administer either ondansetron and/or dexamethasone intraoperatively as prophylaxis. PONV affects up to 30-40% of the general surgical population and up to 80% of high-risk patients, making it one of the most distressing complications of the perioperative period.Uncontrolled PONV prolongs recovery room stay, increases unplanned hospital re-admissions, and is consistently identified by patients and families as one of the most undesirable aspects of the surgical experience. It was ranked in the top 10 research priorities in perioperative medicine in a recent large consumer engagement study involving over 350 children.
Ondansetron, a 5-HT3 receptor antagonist, and dexamethasone, a corticosteroid, are the two most widely used agents for PONV prophylaxis in paediatric anaesthesia, often administered in combination.Dexamethasone exerts well-documented glucocorticoid effects, including modulation of the hypothalamic-pituitary-adrenal (HPA) axis, suppression of endogenous cortisol secretion, and direct actions on brain structures involved in arousal and sleep regulation, including the hippocampus, hypothalamus, and limbic system.a single intraoperative dose of dexamethasone (0.1-0.5 mg/kg) has been shown to produce measurable HPA axis suppression lasting 24-48 hours postoperatively in children, as well as transient elevations in blood glucose and behavioural changes including hyperactivity, irritability, and emotional lability.
Sleep is a critical component of paediatric postoperative recovery. Disrupted postoperative sleep has been associated with increased pain perception, impaired immune function, heightened parental anxiety, and prolonged behavioural disturbance following surgery. Glucocorticoids are known to disrupt sleep architecture, including fragmentation of sleep, suppression of slow-wave sleep, and reductions in total sleep time. In children, the effects of a single perioperative dose of dexamethasone on sleep remain poorly characterised. In contrast, ondansetron does not directly affect the HPA axis or glucocorticoid receptors, and its central effects are limited primarily to 5-HT3 receptor blockade, with no established direct mechanism for sleep disruption. Postoperative negative behavioural changes (PNBC) in children, sometimes referred to as "new-onset behavioural problems", are a recognised sequela of paediatric anaesthesia and surgery, affecting up to 54% of children in the first 2 weeks following surgery. The potential role of perioperative dexamethasone in exacerbating these changes through glucocorticoid-mediated effects on the developing brain has not been systematically examined. Understanding whether the choice of PONV prophylaxis agent influences postoperative sleep quality and behaviour could have important implications for anaesthetic practice and family-centred postoperative care.
This study aims to investigate the impact of intraoperative intravenous dexamethasone vs ondansetron administered for prophylaxis of postoperative nausea and vomiting (PONV) on postoperative sleep, behaviour and recovery in children undergoing general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a mulitcentre double-blinded, randomised, controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Active comparator | Drug: Dexamethasone (IV)Dexamethasone will be sourced from the hospital pharmacy as standard registered medications. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. Dexamethasone will be administered intravenously at 0.2 mg/kg (maximum 8 mg) at the start of procedure.The patient-specific dose of the investigational product will be diluted to 2ml with normal saline to ensure blinding of the anaesthetist in charge of the patient. The trial will mimic this institutional standard practice by providing two syringes to every treating anaesthetist. The first syringe will contain the patient's dose of dexamethasone diluted to 2mL, the second syringe will contain 2mL of normal saline. |
| Ondansetron Group | Active comparator | Drug: Ondansetron ivOndansetron will be administered intravenously at 0.15 mg/kg (maximum 4 mg) 15-30 min before the end of surgery. The dose will be diluted to 2ml with normal saline to ensure blinding by the anaesthetist. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. The first syringe will contain 2mL of normal saline, the second syringe will contain the patient's dose of ondansetron diluted to 2mL. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 - 15 years,
- Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively
- ASA I or III
Key exclusion criteria (11 listed)
- Currently taking regular dexamethasone or ondansetron
- Currently taking regular steroids, including inhaled corticosteroids
- Anaesthetic plan to give dual PONV prophylaxis
- Known hypersensitivity to the active substance or to any of the excipients listed
- Language barriers impeding data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone (IV)Dexamethasone (0.2 mg/kg, maximum 8 mg) will be diluted to 2mL with normal saline and administered intravenously at the start of procedure. | Drug | Dexamethasone Group |
| Ondansetron ivOndansetron (0.15mg/kg, maximum 4mg) will be diluted to 2mL with normal saline and administered intravenously 15-30 minutes before the end of surgery | Drug | Ondansetron Group |
Primary outcome
Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Time frame: Sleep quality will be assessed on day 1 post-surgery
Parent-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
11 secondary outcomes
Compare parent-reported sleep quality preoperatively and on postoperative days 2,3,5 and 7 between children who received dexamethasone and children who received ondansetron intraoperatively.
Time frame: Parent-reported preoperative sleep quality will be collected on the day of surgery and postoperatively on days 2,3,5 and 7.
Compare child-reported (if child is aged over 8 years) sleep quality on postoperative days 1, 2, and 7 between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Time frame: child reported sleep quality will be measure don days 1, 2, and 7 postoperatively
Compare parent reported postoperative recovery on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Time frame: Postoperative recovery will be measured postoperative days 1, 2, 3, 5, and 7
Compare parent reported postoperative behaviour on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Time frame: postoperative behaviour will be measured on postoperative days 1, 2, 3, 5, and 7
Compare parent reported average and maximum pain score on postoperative days 1, 2, 3, 5, and 7 or until the child has returned to normal function between children in the dexamethasone group and children in the ondasetron group
Time frame: postoperative pain will be measured on days 1, 2, 3, 5 and 7 or until the child returns to normal function.
Comparison of sleep disturbances at baseline and 7 days post-surgery between children in the dexamethasone group and children in the ondasetron group
Time frame: Sleep disturbance will be measured at baseline on the day of surgery in the pre-operative holding area and on postoperative day 7
Comparison of the incidence of early postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group
Time frame: From PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first.
Comparison of the use of rescue medication for postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group
Time frame: from PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first
Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative recovery
Time frame: STUBR questionnaire will be administered preoperatively and recovery will be assessed on postoperative days 1,2,3,5, and 7
Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative sleep
Time frame: Parent reported sleep quality will be measured on postopeative days 1,2,3,5, and 7. Child reported sleep quality (if the child is older than 8 years) will be measured on postoperative days 1,2, and 7.
Impact of sedative premedication on postoperative delirium
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria met
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 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Sleep Quality
Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery
Postoperative Sleep Disturbance, Thoracoscopic Surgery
Recruiting
Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery
Thoracic Surgical Procedures
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
Not yet recruiting
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting
Recruiting
Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy, Postoperative Quality of Recovery
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone (IV) and Ondansetron iv in people with Postoperative Sleep Quality and Postoperative Behaviour, run by Telethon Kids Institute at 3 sites in 2 countries.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Britta S von Ungern-Sternberg, MD, PhD (+61864564806, britta.regli-vonungern@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic. (time frame: Sleep quality will be assessed on day 1 post-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 20 Aug 2026.