Adenotonsillar HypertrophyNCT07045597
Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.
A study testing intranasal normal saline for preanasthetic sedation for Adenotonsillectomy and intranasal midazolam for preanasthetic sedation for Adenotonsillectomy in people with Adenotonsillar Hypertrophy, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Adenotonsillar Hypertrophy
- What is being tested?
- intranasal normal saline for preanasthetic sedation for Adenotonsillectomy and intranasal midazolam for preanasthetic sedation for Adenotonsillectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patient of age 2-6 y
- ASA I-II children
- child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.
- Conditions
- Adenotonsillar Hypertrophy
- Being tested
- intranasal normal saline for preanasthetic sedation for Adenotonsillectomy, intranasal midazolam for preanasthetic sedation for Adenotonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal normal saline for preanasthetic sedation for AdenotonsillectomyDrug
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 AdenotonsillectomyDrug
preschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| intranasal normal saline for preanasthetic sedation for Adenotonsillectomy | Placebo comparator | Patient will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group Receives: Drug: intranasal normal saline for preanasthetic sedation for Adenotonsillectomy |
| intranasal midazolam for preanasthetic sedation for Adenotonsillectomy | Active comparator | Patient will receive intranasal midazolam by dose 0.2 mg/kg Receives: Drug: intranasal midazolam for preanasthetic sedation for Adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedative effect of preanesthetic Midazolam
Glasgow coma scale
Measured: 5 minutes,10 minutes and 15 minutes preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start13 Mar 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adenotonsillar HypertrophyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ramadan Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045597
- Sponsor's protocol ID
- Soh-Med--25-3-08MS
- Status last verified
- May 2026
- First submitted
- 14 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Korsch BM. The child and the operating room. Anesthesiology. 1975 Aug;43(2):251-7. doi: 10.1097/00000542-197508000-00010. No abstract available.
PubMed 1098522Rochette 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.
PubMed 6497079Rita 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.
PubMed 2932039
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.
- ClinicalTrials.gov ID
- NCT07045597
- Acronym / sponsor ID
- Soh-Med--25-3-08MS
- Conditions
- Adenotonsillar Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal normal saline for preanasthetic sedation for Adenotonsillectomy | Placebo comparator | Drug: intranasal normal saline for preanasthetic sedation for AdenotonsillectomyPatient 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 | Active comparator | Drug: intranasal midazolam for preanasthetic sedation for AdenotonsillectomyPatient will receive intranasal midazolam by dose 0.2 mg/kg |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pediatric patient of age 2-6 y
- ASA I-II children
- child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intranasal normal saline for preanasthetic sedation for Adenotonsillectomypreschool 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 | Drug | intranasal normal saline for preanasthetic sedation for Adenotonsillectomy |
| intranasal midazolam for preanasthetic sedation for Adenotonsillectomypreschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg | Drug | intranasal midazolam for preanasthetic sedation for Adenotonsillectomy |
Primary outcome
sedative effect of preanesthetic Midazolam
Time frame: 5 minutes,10 minutes and 15 minutes preoperative
Glasgow coma scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 1098522Korsch BM. The child and the operating room. Anesthesiology. 1975 Aug;43(2):251-7. doi: 10.1097/00000542-197508000-00010. No abstract available.
- Background: PubMed 6497079Rochette 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.
- Background: PubMed 2932039Rita 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal normal saline for preanasthetic sedation for Adenotonsillectomy and intranasal midazolam for preanasthetic sedation for Adenotonsillectomy in people with Adenotonsillar Hypertrophy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedative effect of preanesthetic Midazolam (time frame: 5 minutes,10 minutes and 15 minutes preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045597, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.