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NCT04836962
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
NA trial testing normal saline in Pediatric Patients Undergoing Hypospadias Surgery in 46 participants. Completed in 31 January 2022.
31 January 2022
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 7 May 2021 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- normal saline
- dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Pediatric Patients Undergoing Hypospadias Surgery — all drugs for Pediatric Patients Undergoing Hypospadias Surgery →
Sponsor
Yonsei University
Who can join
Adults 6 Months to 3, male only, with Pediatric Patients Undergoing Hypospadias Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
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 NCT04836962
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Other Yonsei University trials
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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 NCT04836962 (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: 23 August 2022
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/NCT04836962.
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