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Recruiting NCT07279883

NCT07279883 Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery

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Clinical Trial Summary
NCT ID NCT07279883
Status Recruiting
Phase
Sponsor Karolinska Institutet
Condition Cleft Palate Children
Study Type OBSERVATIONAL
Enrollment 150 participants
Start Date 2017-01-01
Primary Completion 2018-12-31

Eligibility & Interventions

Sex All sexes
Min Age 3 Months
Max Age 15 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 150 participants in total. It began in 2017-01-01 with a primary completion date of 2018-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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 opioids. Routine use of SZMNB was introduced at the pediatric surgery unit at Karolinska University Hospital in late 2017. A before-and-after evaluation project based on retrospective chart review was initiated in 2018 but was not completed due to the COVID-19 pandemic. The aim of this project is to investigate whether the introduction of SZMNB has reduced postoperative morphine requirements and opioid-related side effects, and whether this has resulted in shorter hospital stays (earlier discharge) after cleft palate repair.

Eligibility Criteria

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). Exclusion Criteria: not fulfilling inclusion cirteria \-

Contact & Investigator

Central Contact

Jacob KarlssonM, MD PhD

✉ jacob.karlsson.1@ki.se

📞 +460812370000

Principal Investigator

Märit Lundblad, MD PhD

PRINCIPAL INVESTIGATOR

Karolinska Institutet

Frequently Asked Questions

Who can join the NCT07279883 clinical trial?

This trial is open to participants of all sexes, aged 3 Months or older, up to 15 Years, studying Cleft Palate Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07279883 currently recruiting?

Yes, NCT07279883 is actively recruiting participants. Contact the research team at jacob.karlsson.1@ki.se for enrollment information.

Where is the NCT07279883 trial being conducted?

This trial is being conducted at Stockholm, Sweden.

Who is sponsoring the NCT07279883 clinical trial?

NCT07279883 is sponsored by Karolinska Institutet. The principal investigator is Märit Lundblad, MD PhD at Karolinska Institutet. The trial plans to enroll 150 participants.

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