A Phase 4 interventional study of Dexamethasone (IV) and Ondansetron iv in Postoperative Sleep Quality, Postoperative Behaviour and Postoperative Recovery in Children, sponsored by Telethon Kids Institute. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Telethon Kids Institute · Phase 4, Interventional, and Prevention
Among 82 studies testing dexamethasone in Postoperative Nausea and Vomiting — 10 open to participants now, 11 under way, 2 of them phase 3. Dexamethasone · Postoperative Nausea and Vomiting.
Among the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting, this one is the 8th largest by planned enrollment, is one of 3 that started in 2026, is one of 37 in phase 4, reaches primary completion later than 10 of the 10 other live ones, and was the 82nd registered.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
Browse Postoperative Nausea and Vomiting studies →10 of the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting are open now, in 7 countries. Recruiting first, the newest first:
Beijing Tiantan Hospital · Sites in China
Ages 18–65
Beijing Tiantan Hospital · Sites in China
Ages 18–65
Mansoura University · Sites in Egypt
Ages 18+
Balgrist University Hospital · Sites in Switzerland
Ages 18–99 · Healthy volunteers
University Medical Center Ho Chi Minh City (UMC) · Sites in Vietnam
Ages 18+ · Women only
By country, each count listing its studies:
Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 65 Postoperative Nausea and Vomiting studies recruiting now, 22 (34%) set no upper age limit and 37 (57%) stop at 75 or younger; 14 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 15 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 12 · Phase 4 37
First in 2002; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Median enrollment 121 across the 82 interventional studies. Of the 59 that completed or were terminated, 16 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 82 has an industry lead sponsor. The 10 most frequent:
Telethon Kids Institute is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Telethon Kids Institute has 1 study filed under Postoperative Nausea and Vomiting — fewer than ten, so there is no comparison to draw.
4 of the studies testing dexamethasone in Postoperative Nausea and Vomiting that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06997419Beijing Tiantan HospitalDexamethasone Palmitate for PONV After Open Surgery | 2026-11-30 |
| NCT07099222University of ArizonaEfficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks | 2026-12-31 |
| NCT06988124Beijing Tiantan HospitalDexamethasone Palmitate for PONV After Craniotomy | 2027-05-01 |
| NCT07615595University Medical Center Ho Chi Minh City (UMC)Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery | 2027-07-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexamethasone (IV)
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.
Drug: Ondansetron 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.
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
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.
Time frame: Sleep quality will be assessed on day 1 post-surgery
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.
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.
Child reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep
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
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.
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
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,
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
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.
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
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
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
Postoperative nausea and vomiting will as self-reported by the patient or parent reported
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
Rescue medications given will be as recorded on the patient's medication chart
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
postoperative recovery will be measured using the Pediatric Scale for Quality of Recovery (PedSQoR)
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
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.
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
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.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria met
Impact of sedative premedication on postoperative delirium
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria met
Impact of sedative premedication on postoperative recovery
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.
Time frame: Postoperative days 1,2,3,5, and 7
Impact of sedative premedication on postoperative sleep
sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Time frame: postoperative days 1,2,3,5, and 7
Impact of anaesthesia management 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.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria met
Impact of anaesthesia management on postoperative recovery
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.
Time frame: Postoperative days 1,2,3,5, and 7
Impact of anaesthesia management on postoperative sleep
sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Time frame: postoperative days 1,2,3,5, and 7
Impact of induction compliance on postoperative delirium
postoperative delirium will be measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria is met
Impact of induction compliance on postoperative recovery
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.
Time frame: Postoperative days 1,2,3,5, and 7
Impact of induction compliance on postoperative sleep
Sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Time frame: Postoperative days 1,2,3,5, and 7
Time of first drink postoperatively between patients in the dexamethasone group and patients in the ondansetron group
time of first drink as recorded in medical records
Time frame: Post-operatively on the day of surgery (day 0) from the time the patient is first awake in the post anaesthetic care unit until they are discharged from the hospital (day 0 or day 1 post-op) assessed in hours.
Time of first food postoperatively between patients in the dexamethasone group and patients in the ondansetron group
Time of first drink as recorded in medical records
Time frame: Post-operatively on the day of surgery (day 0) from the time the patient is first awake in the post anaesthetic care unit until they are discharged from the hospital (day 0 or day 1 post-op) assessed in hours.
Assessment of the parental and child satisfaction with the perioperative experience.
Assessed on a 5-point Likert scale - very dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, very satisfied
Time frame: Postoperative days 1 and 7
Compare the incidence of emergence delirium between patients in the dexamethasone group and patients in the ondasetron group
Emergence delirium will be measured 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.
Time frame: Post-operatively from PACU arrival until PACU discharge criteria met
Compare the incidence of emergence delirium between patients in the dexamethasone group and patients in the ondansetron group
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anaesthesia Emergence Delirium (PAED) scale in the post anaesthetic care unit (PACU). The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Time frame: Post-operatively from PACU arrival until PACU discharge criteria met
Compare the incidence of perioperative respiratory adverse events between patients in the dexamethasone group and patients in the ondansetron group
Perioperative respiratory adverse events (PRAE) are defined as: Major PRAE: laryngospasm or bronchospasm (as determined by the anaesthetist or recovery nurse) or desaturation \<85% SpO2 for more than 1 minute on pulse oximetry. Minor PRAE: desaturation (\<95% SpO2 for more than 10 seconds on pulse oximetry), airway obstruction, severe coughing, post-operative stridor. Each individual PRAE (laryngospasm, bronchospasm, desaturation, airway obstruction, severe persistent coughing and post-operative stridor) will be considered separately. PONV will be assessed by observing any incidence of nausea or vomiting post-operatively, and any administration of antiemetic medication.
Time frame: PRAE will be assessed by the anaesthetist intraoperatively - during anaesthetic induction, maintenance and emergence and postoperatively by the recovery nurse while in the post-anaesthetic care unit (PACU).
Compare the incidence of unplanned medical representations for pain or any other reason between patients in the dexamethasone group and patients in the ondansetron group
Parent-reported presentations to the emergency department, outpatient clinics or patient's GP
Time frame: Postoperative days 1,2,3,5, and 7
Comparison of overnight actigaraphy monitoring between patients who opted in for monitoring in the ondansetron group and patients in the dexamethasone group
Actigraphy will be measured using the Actigraph GT9X
Time frame: Patients will wear the monitor for 3 nights preoperatively and 3 nights postoperatively
Comparison of preoperative and post operative overnight pulse oximetry monitoring between patients in the dexamethasone group and patients in the ondansetron group
Pulse oximetry will me measured using a wrist-worn pulse oximeter device (WristOx 3150)
Time frame: Patients will wear the oximeter for 3 nights preoperatively and 3 nights postoperatively
Compare the transcutaneous carbon dioxide levels on the night of surgery between patients in the dexamethasone group and patients in the ondansetron group
Transcutaneous carbon dioxide will be measured using the non-invasive digital monitoring system, SenTec.
Time frame: Monitoring will be done postoperatively on the night of surgery for an estimate of 12 hours overnight from approximately 7pm day 0 to 7am on day 1 post surgery (if patient is admitted)
Compare the postoperative outcomes between neurotypical and neurodiverse children
Neurodiversity will be assessed via parent report of whether the child has a formal diagnosis of autism and/or ADHD, as well as parent completion of a brief item set based on DSM-5-TR criteria for autism and ADHD in childhood (Strengths and Difficulties Questionnaire) as well as the Perth Autism Scale.
Time frame: Parent reported ADHD or Autism diagnosis will be collected preoperatively.
Impact of anaesthesia management on postoperative delirium
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria met
Impact of induction compliance on postoperative delirium
postoperative delirium will be measured 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.
Time frame: Delirium will be assessed from PACU arrival until PACU discharge criteria is met
Plan to share: No
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Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
Of 67 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 36 months is above that.
Counting every sponsor, half of 67 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Ondansetron
Postoperative Nausea and Vomiting →
Telethon Kids Institute