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NCT03261921
Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery
Phase 1 trial testing Dexamethasone in Caudal Block in 63 participants. Completed in 7 July 2017.
22 June 2017
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 63 |
| Start date | 5 June 2016 |
| Primary completion | 22 June 2017 |
| Estimated completion | 7 July 2017 |
Drugs / interventions tested
- Dexamethasone (dexamethasone) — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Bupivacaine (BUPIVACAINE) — full drug profile →
Conditions studied
- Caudal Block — all drugs for Caudal Block →
Sponsor
Cairo University
Who can join
Adults 1 to 6, male only, with Caudal Block. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses
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 NCT03261921
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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 NCT03261921 (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 Cairo University
- Last refreshed: 25 August 2017
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/NCT03261921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing