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NCT05758090
Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years
NA trial testing NIPE monitor in Post Operative Pain in 70 participants. Completed in 31 December 2023.
31 December 2023
Quick facts
| Lead sponsor | Khon Kaen University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 10 March 2023 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- NIPE monitor
- Control
Conditions studied
- Post Operative Pain — all drugs for Post Operative Pain →
- Analgesia — all drugs for Analgesia →
- Children, Only — all drugs for Children, Only →
- Narcotic Use — all drugs for Narcotic Use →
Sponsor
Khon Kaen University
Who can join
Adults 1 Month to 2, any sex, with Post Operative Pain or Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effectiveness of newborn infant parasympathetic evaluation (NIPE) index for guiding intraoperative fentanyl administration in children under 2 years: a randomized controlled trial.
Sripadungkul D, Tribuddharat S, Sathitkarnmanee T, Muenpirom P, et al · · 2024 · PMID 39399441 · DOI 10.7717/peerj.18267
Verify or expand the search:
- PubMed search for NCT05758090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NIPE monitor
Trials testing the same drug.
- NCT04381637 — Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia · NA · completed
Other recruiting trials for Post Operative Pain
Currently open trials in the same condition.
- NCT06779604 — Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery · recruiting
- NCT07223580 — A Study Of Corticosteroid On Postoperative Pain After Ureteroscopy For Urinary Calculi · Phase 4 · recruiting
- NCT07227064 — Methadone in THA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
- NCT07226076 — Methadone in TKA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
- NCT07349810 — Post Operative Infusion Pump Pain Study · Phase 4 · recruiting
Other Khon Kaen University trials
Trials by the same sponsor.
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- NCT07054775 — Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section · Phase 4 · recruiting
- NCT06994520 — Efficacy of Topical Cannabidiol for Eczema · Phase 2 · active not recruiting
- NCT06958029 — Postoperative Atrial Fibrillation in Cardiac Surgery · recruiting
- NCT06289257 — Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study · completed
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 NCT05758090 (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 Khon Kaen University
- Last refreshed: 23 April 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/NCT05758090.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing