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Die klinische Studie NCT07279883 für Kinder mit Gaumenspalte ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery 150 Pädiatrisch

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Die klinische Studie NCT07279883 ist eine beobachtungsstudie zur Untersuchung von Kinder mit Gaumenspalte und hat den Status offene rekrutierung. Die Studie startete am 1. Januar 2017 und soll 150 Teilnehmer aufnehmen. Durchgeführt von Karolinska-Institut ist der Abschluss für 31. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. Dezember 2025 aktualisiert.
Kurzbeschreibung
Cleft lip and palate (CLP) is one of the most common congenital malformations and requires repeated surgical correction during childhood. Surgical repair is often associated with significant postoperative pain, traditionally managed with morphine, which carries a risk of undesirable side effects. The suprazygomatic maxillary nerve block (SZMNB) has been shown to provide effective analgesia and may reduce the need for...Mehr anzeigen
Ausführliche Beschreibung
Scientific background and rationale Cleft lip and palate (CLP) is one of the most common congenital malformations and often requires repeated surgical corrections during childhood. These procedures are associated with considerable postoperative pain that may delay recovery and prolong hospital stay. Traditionally, systemic analgesics (opioids, NSAIDs, and acetaminophen given intravenously or orally) have been used, b...Mehr anzeigen
Offizieller Titel

Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery: a Before-and-after Chart Review Study

Erkrankungen
Kinder mit Gaumenspalte
Weitere Studien-IDs
  • Dnr 2025-04058-01
NCT-Nummer
NCT07279883
Studienbeginn (tatsächlich)
2017-01-01
Zuletzt aktualisiert
2025-12-12
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
150
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Cleft palate
Suprazygomatic maxillary nerve block
Pediatric anesthesia
Regional anesthesia
Nerve block
opiod consumtion
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Pre-implementation group (2017)
Children who received standard systemic analgesia (intravenous and/or oral opioids, acetaminophen, and NSAIDs) without nerve block.
Nicht zutreffend
Post-implementation group (2018)
Children who, in addition to standard systemic analgesia, received a suprazygomatic maxillary nerve block (SZMNB) as part of routine perioperative care.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Length of hospital stay
Time (in hours) from arrival at the postoperative recovery unit to the time of documented discharge by nursing staff in the electronic medical record (TakeCare).
Through out the study completion, an average of approximately 5 days.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Total postoperative opioid consumption
Total amount of morphine (mg/kg) or morphine-equivalent opioids administered intravenously and/or orally during the postoperative hospital stay.
Through out the study completion, an average of approximately 5 days.
Need for supplemental analgesia
Proportion of patients requiring additional rescue analgesics beyond the standard regimen (e.g., extra opioid or NSAID doses).
During postoperative hospital stay.
Incidence of opioid-related side effects
Occurrence of opioid-related adverse effects such as nausea, vomiting, or reduced level of consciousness, as documented in medical records.
Through out the study completion, an average of approximately 5 days.
Pain scores assessed with validated scale FLACC and VAS
Postoperative pain score assessed using FLACC and VAS . High number indicates worse outcome
From baseline start of study to after 24 hours.
Teilnahme-Assistent
Eignungskriterien

criteria for participating in the study

  • children aged 3 months to 15 years.
  • Underwent cleft palate (LKG) surgery between 2017-2018.
  • Available and complete medical records including perioperative notes, anesthesia documentation, and discharge summaries.
  • Received either standard systemic analgesia alone (2017) or standard analgesia plus suprazygomatic maxillary nerve block (SZMNB) (2018).

not fulfilling inclusion cirteria

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Karolinska Institutet logoKarolinska-Institut
Verantwortliche Partei
Jacob Karlsson, Hauptprüfer, Associate Professor, Karolinska University Hospital
Zentrale Studienkontakte
Kontakt: Jacob KarlssonM, MD PhD, +460812370000, [email protected]
1 Studienstandorte in 1 Ländern
Stockholm, SE-171 76, Sweden
Märit Lundblad, Kontakt, [email protected]
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