Effect of oral medications on preoperative anxiety in children
PERIOPERATIVE EFFECTS OF ORAL DEXMEDETOMIDINE, KETAMINE, OR MIDAZOLAM PREMEDICATION IN CHILDREN UNDERGOING ADENOTONSILLECTOMY
PHASE4 · Menoufia University · NCT05874245
This study tests whether giving children oral medications before surgery can help reduce their anxiety and make the whole experience easier for them and their parents.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Menoufia University (other) |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT05874245 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral Dexmedetomidine, Ketamine, and Midazolam as preoperative medications to reduce anxiety in children undergoing elective adenotonsillectomy. The study aims to enhance anesthetic induction while minimizing adverse effects and improving the overall surgical experience for both children and their parents. By administering these medications, the trial seeks to decrease the incidence of postoperative agitation and related complications. The approach focuses on ensuring a safe and painless premedication process that facilitates smoother anesthesia induction.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 8 years who are scheduled for elective, uncomplicated adenotonsillectomy.
Not a fit: Patients with a history of allergy to the study drugs or those with neurological, psychological, or cardio-respiratory illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce preoperative anxiety and postoperative complications in children undergoing surgery.
How similar studies have performed: Other studies have shown promising results with similar pharmacological approaches to reduce preoperative anxiety in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients within the age range of 3 to 8 years old. * Elective non complicated adenotonsillectomy. * ASA I or II physical status. Exclusion Criteria: * Refusal of the patient's parents or legal guardians to give informed consent. * History of allergy to any of the study drugs. * Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery. * Neurological and/or psychological diseases. * Associated cardio-respiratory illness
Where this trial is running
Shibīn Al Kawm, Menoufia
- Menoufia university hospitails — Shibīn Al Kawm, Menoufia, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ahmed Abosayar, Assisstant lecturer
- Email: Aabosayar@gmail.com
- Phone: +201064070141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia