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NCT00403806
Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised, Placebo-controlled, Double-blind, Dose-finding Study
Phase 4 trial testing dexamethasone in Postoperative Nausea and Vomiting in 215 participants. Terminated before completion.
1 December 2007
Quick facts
| Lead sponsor | University Hospital, Geneva |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 215 |
| Start date | 1 February 2005 |
| Primary completion | 1 December 2007 |
| Estimated completion | 1 December 2007 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- dexamethasone (dexamethasone) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- dexamethasone (dexamethasone) — full drug profile →
- Saline
Conditions studied
- Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →
- Postoperative Pain — all drugs for Postoperative Pain →
Sponsor
University Hospital, Geneva
Who can join
Adults 3 to 16, any sex, with Postoperative Nausea and Vomiting or Postoperative Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy
Time frame: 24 hours postoperatively
Sponsor's own description
Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory drugs (NSAIDs)widely used for paincontrol increase the risk of postoperative bleeding and reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy. Antiemetic and analgesic dose-response has never been established.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial.
Czarnetzki C, Elia N, Lysakowski C, Dumont L, et al · · 2008 · cited 115× · PMID 19066382 · DOI 10.1001/jama.2008.794
Verify or expand the search:
- PubMed search for NCT00403806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Postoperative Nausea and Vomiting
Currently open trials in the same condition.
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Other University Hospital, Geneva trials
Trials by the same sponsor.
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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 NCT00403806 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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, Geneva
- Last refreshed: 13 August 2010
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/NCT00403806.
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