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NCT04527393
Individualized Analgesia for Pediatric Adenotonsillectomy
Phase 4 trial testing Individualized oral morphine in Adenotonsillectomy in 542 participants. Completed in 10 January 2024.
10 January 2024
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 542 |
| Start date | 1 May 2022 |
| Primary completion | 10 January 2024 |
| Estimated completion | 10 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Individualized oral morphine — full drug profile →
- Conventional oral morphine — full drug profile →
Conditions studied
- Adenotonsillectomy — all drugs for Adenotonsillectomy →
- Analgesia — all drugs for Analgesia →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 3 to 10, any sex, with Adenotonsillectomy or Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The performance of a post-induction fentanyl-test in predicting postoperative respiratory adverse events in children after adenotonsillectomy.
Liu HE, He L. · · 2024 · PMID 38935059 · DOI 10.5664/jcsm.11262
Verify or expand the search:
- PubMed search for NCT04527393
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Adenotonsillectomy
Currently open trials in the same condition.
- NCT07345715 — Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy · NA · recruiting
- NCT06882980 — Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy · NA · recruiting
- NCT07305168 — A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea · recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
- NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting
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 NCT04527393 (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 Children's Hospital of Fudan University
- Last refreshed: 28 February 2024
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/NCT04527393.
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