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Search / Trial NCT04928391

A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Launched by ASSIUT UNIVERSITY · Jun 10, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how well two different medications, dexmedetomidine and nalbuphine, can help prevent agitation in young children right after they have surgery to fix a cleft palate. The goal is to see which medication works better in keeping children calm during the recovery period immediately after their operation.

The trial is looking for children between the ages of 1 and 7 who are healthy enough to undergo this surgery, specifically those who do not have certain medical conditions like increased pressure in the brain or developmental delays. If a child participates, they will receive one of the two medications through an IV right after their surgery. The study is currently recruiting participants, and it’s important for families to be aware that this research could help improve care for children undergoing similar surgeries in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
  • Elective cleft palate repair ± cleft lip surgery under general anesthesia.
  • Exclusion Criteria:
  • Ventriculo-peritoneal shunt
  • Suspected meningitis
  • Congenital hydrocephalus
  • Clinical signs of suspected increased intracranial pressure
  • On treatment for seizures or metabolic diseases
  • Children with developmental delay
  • Hypersensitivity to dexmedetomidine or nalbuphine

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, Assuit, Egypt

Assiut, Assuit, Egypt

Patients applied

0 patients applied

Trial Officials

Omar Soliman

Study Director

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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