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NCT03343002
Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy
NA trial testing fentanyl at 10-15 min before end of surgery in Follicular Tonsillitis (Chronic) in 140 participants. Completed in 27 August 2018.
27 August 2018
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 26 November 2017 |
| Primary completion | 27 August 2018 |
| Estimated completion | 27 August 2018 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- fentanyl at 10-15 min before end of surgery — full drug profile →
- fentanyl at end of surgery — full drug profile →
Conditions studied
- Follicular Tonsillitis (Chronic) — all drugs for Follicular Tonsillitis (Chronic) →
Sponsor
Yonsei University
Who can join
Adults 3 to 7, any sex, with Follicular Tonsillitis (Chronic). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in postoperative pain in children receiving tonsillectomy. However, fentanyl can cause postoperative nausea and vomiting (PONV), which is a main target side effect that medical staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may be different depending on the time of administration of fentanyl. However, the research design of patients enrolled in each study, such as the age, the name of the operation, and the method of anesthesia, is not identical. The aim of this study was to evaluate the efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective randomized controlled trial. Secondary outcomes include incidence and severity of emergence agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, side effects.
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 NCT03343002
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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 NCT03343002 (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 Yonsei University
- Last refreshed: 8 August 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/NCT03343002.
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