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NCT03592537
Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children
Phase 2, PHASE3 trial testing Fentanyl in Postoperative Analgesia in 90 participants. Completed in 14 May 2021.
20 April 2021
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 15 August 2018 |
| Primary completion | 20 April 2021 |
| Estimated completion | 14 May 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Fentanyl (fentanyl) — full drug profile →
- Midazolam
- Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →
Conditions studied
- Postoperative Analgesia — all drugs for Postoperative Analgesia →
Sponsor
Assiut University
Who can join
Adults 6 to 8, any sex, with Postoperative Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia. Secondary outcomes of study will be; * is to compare the duration of postoperative analgesia. * comparative assessment regarding time for first analgesic request ,total analgesic requirements. * Hemodynamic changes or other adverse events will be recorded.
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 NCT03592537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03592537 (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 Assiut University
- Last refreshed: 10 June 2021
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/NCT03592537.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing