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NCT03398044
Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy
NA trial testing Dexamethasone in Nasal Obstruction in 200 participants. Completed in 31 March 2019.
31 December 2018
Quick facts
| Lead sponsor | University Hospital Ostrava |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 January 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Dexamethasone (dexamethasone) — full drug profile →
- Placebo
Conditions studied
- Nasal Obstruction — all drugs for Nasal Obstruction →
- Nasopharyngeal Obstruction — all drugs for Nasopharyngeal Obstruction →
- Snoring — all drugs for Snoring →
- Apnea, Obstructive — all drugs for Apnea, Obstructive →
Sponsor
University Hospital Ostrava
Who can join
Adults 3 to 15, any sex, with Nasal Obstruction or Nasopharyngeal Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adenotomy, together with tonsillectomy, belongs among the most frequently performed surgical procedures in paediatric patients. These surgical procedures are associated with the second highest incidence of post-operative nausea and vomiting (PONV) (following strabism correction surgery) in paediatric surgery. PONV is associated, apart from the discomfort for the child, with a number of complications: dehydration, metabolic disruption or danger of haemorrhage and aspiration of the gastric content. Adenotomy is a typologically completely different surgical procedure, with a different target structure of the surgery, and the length and invasiveness of the procedure. Thus, it is possible to expect a difference in PONV incidence when compared to tonsillectomy. Adenotomy is a surgical procedure performed namely in children of the pre-school age. This is associated, among others, also with the problem of objectivization of post-operative nausea, which is very difficult to verbalize in small children, being a subjective feeling of body discomfort. It is possible to expect that the overall incidence of PONV will be significantly underestimated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03398044
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Nasal Obstruction
Currently open trials in the same condition.
- NCT06580210 — Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Labora · recruiting
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- NCT05920330 — Nasal Obstruction and Olfactory Losses · NA · recruiting
Other University Hospital Ostrava trials
Trials by the same sponsor.
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- NCT07374289 — On Scene ECPR in Ostrava · NA · recruiting
- NCT07041086 — Prehospital ECPR in Moravia Silesia Region · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03398044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Ostrava
- Last refreshed: 5 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03398044.
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