Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

NCT ID: NCT07045597

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2025-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenotonsillar Hypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

Patient will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group

Group Type PLACEBO_COMPARATOR

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

Intervention Type DRUG

preschool children that will undergo adenotonsillectomy will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group

intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

Patient will receive intranasal midazolam by dose 0.2 mg/kg

Group Type ACTIVE_COMPARATOR

intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

Intervention Type DRUG

preschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

preschool children that will undergo adenotonsillectomy will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group

Intervention Type DRUG

intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

preschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pediatric patient of age 2-6 y
* ASA I-II children
* child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy

Exclusion Criteria

* Parent refusal .
* Allergy to any of the drug included in this study
* Nasal infection , allergy and pathology
* Mentally affected children , neurological disable .
* Blood disesases and any other contraindications of surgery
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ramadan Hassan

Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed R Hassan, Resident

Role: CONTACT

01012552154

Ahmed E Abdelrahman, Professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magdy M Amin, Professor

Role: primary

01090801900

References

Explore related publications, articles, or registry entries linked to this study.

Korsch BM. The child and the operating room. Anesthesiology. 1975 Aug;43(2):251-7. doi: 10.1097/00000542-197508000-00010. No abstract available.

Reference Type BACKGROUND
PMID: 1098522 (View on PubMed)

Rochette A, Julia JM, Evrard O, Ricard C, Jullien Y, Du Cailar J. [Intramuscular premedication with midazolam in infants and children]. Ann Fr Anesth Reanim. 1984;3(5):346-50. doi: 10.1016/s0750-7658(84)80071-4. French.

Reference Type BACKGROUND
PMID: 6497079 (View on PubMed)

Rita L, Seleny FL, Mazurek A, Rabins SY. Intramuscular midazolam for pediatric preanesthetic sedation: a double-blind controlled study with morphine. Anesthesiology. 1985 Nov;63(5):528-31. doi: 10.1097/00000542-198511000-00009. No abstract available.

Reference Type BACKGROUND
PMID: 2932039 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med--25-3-08MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.