DexmedetomidineNCT07564037
Nebulized Dexmedetomidine, Ketamine, or Midazolam in Children Undergoing Adenotonsillectomy
A study testing Group K:nebulized ketamine group, Group D:dexmedetomidine group and Group M: midazolam group in people with Dexmedetomidine and Adenotonsillectomy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dexmedetomidine, Adenotonsillectomy, Midazolam
- What is being tested?
- Group K:nebulized ketamine group, Group D:dexmedetomidine group and Group M: midazolam group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 30 Dec 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 3-7 years.
- Both sexes.
- American society of anesthesiologists (ASA) physical status (I-II).
- Children undergoing adenotonsillectomy.
Who cannot join
- Patients with known allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Congenital heart disease.
- Use of psychotropic medication, and mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Nebulized Dexmedetomidine, Ketamine, or Midazolam for Premedication in Children Undergoing Adenotonsillectomy
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
Read the detailed description
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
Primary outcome:
- A five-point sedation score on arrival in the operating room 30 min after drug administration.
Secondary outcomes:
- Parental separation anxiety scale.
- Medication and mask acceptance scales.
- Hemodynamic variables.
- Recovery time.
- Postoperative face, legs, activity, cry, and consolability (FLACC) scale.
- Emergence Agitation scale.
- Adverse effects.
- Conditions
- Dexmedetomidine, Adenotonsillectomy, Midazolam, Children
- Being tested
- Group K:nebulized ketamine group, Group D:dexmedetomidine group, Group M: midazolam group
- Keywords
- Midazolam, Nebulized, Dexmedetomidine, Adenotonsillectomy, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group K:nebulized ketamine groupDrug
Patients will receive nebulized ketamine 2 mg kg -1
Group D:dexmedetomidine groupDrug
Patients will receive dexmedetomidine 2 mcg kg -1
Group M: midazolam groupDrug
Patients will receive midazolam 0.2 mg kg -1
| Study group | Role | What they receive |
|---|---|---|
| Group K :nebulized ketamine group | Experimental | Group K: Patients will receive nebulized ketamine 2 mg kg -1 Receives: Drug: Group K:nebulized ketamine group |
| Group D: dexmedetomidine group | Experimental | Group D: Patients will receive dexmedetomidine 2 mcg kg -1 Receives: Drug: Group D:dexmedetomidine group |
| Group M:midazolam group | Experimental | (Group M): Patients will receive midazolam 0.2 mg kg -1 Receives: Drug: Group M: midazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A five-point sedation score on arrival in the operating room
Sedation level will be assessed at the same time points mentioned above using a five-point sedation scale score as follows: 1= agitated, 2= alert, 3= calm, 4= drowsy, and 5=asleep . A score ≥ 3 will be considered as acceptable sedation.
Measured: 30 min after drug administration
Secondary outcomes (1)
Parental separation anxiety scale
parental separation will be assessed by a four-point parental separation anxiety scale (PSAS) as follows: 1= easy separation, 2= whimpers, but is easily reassured, not clinging, 3= cries and cannot be easily reassured, but not clinging to parents, and 4= crying and clinging to parents. PSAS scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 will be classified as difficult separation .
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Nov 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa Mohamed Abd Elfatah Elrefaie, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564037
- Sponsor's protocol ID
- 36264MS748/11/24
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available when it needed
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nebulized Dexmedetomidine, Ketamine, or Midazolam for Premedication in Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07564037
- Acronym / sponsor ID
- 36264MS748/11/24
- Conditions
- Dexmedetomidine, Adenotonsillectomy, Midazolam, Children
- Keywords
- Midazolam, Nebulized, Dexmedetomidine, Adenotonsillectomy, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 4 May 2026 (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.
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
Detailed description
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
Primary outcome:
- A five-point sedation score on arrival in the operating room 30 min after drug administration.
Secondary outcomes:
- Parental separation anxiety scale.
- Medication and mask acceptance scales.
- Hemodynamic variables.
- Recovery time.
- Postoperative face, legs, activity, cry, and consolability (FLACC) scale.
- Emergence Agitation scale.
- Adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group K :nebulized ketamine group | Experimental | Drug: Group K:nebulized ketamine groupGroup K: Patients will receive nebulized ketamine 2 mg kg -1 |
| Group D: dexmedetomidine group | Experimental | Drug: Group D:dexmedetomidine groupGroup D: Patients will receive dexmedetomidine 2 mcg kg -1 |
| Group M:midazolam group | Experimental | Drug: Group M: midazolam group(Group M): Patients will receive midazolam 0.2 mg kg -1 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged between 3-7 years.
- Both sexes.
- American society of anesthesiologists (ASA) physical status (I-II).
- Children undergoing adenotonsillectomy.
Key exclusion criteria (5 listed)
- Patients with known allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Congenital heart disease.
- Use of psychotropic medication, and mental retardation
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 |
|---|---|---|
| Group K:nebulized ketamine groupPatients will receive nebulized ketamine 2 mg kg -1 | Drug | Group K :nebulized ketamine group |
| Group D:dexmedetomidine groupPatients will receive dexmedetomidine 2 mcg kg -1 | Drug | Group D: dexmedetomidine group |
| Group M: midazolam groupPatients will receive midazolam 0.2 mg kg -1 | Drug | Group M:midazolam group |
Primary outcome
A five-point sedation score on arrival in the operating room
Time frame: 30 min after drug administration
Sedation level will be assessed at the same time points mentioned above using a five-point sedation scale score as follows: 1= agitated, 2= alert, 3= calm, 4= drowsy, and 5=asleep . A score ≥ 3 will be considered as acceptable sedation.
1 secondary outcome
Parental separation anxiety scale
Time frame: 2 hours
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 7 May 2026.
- Individual participant dataSharing planned: Yes. It will be available when it needed
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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 Group K:nebulized ketamine group, Group D:dexmedetomidine group and Group M: midazolam group in people with Dexmedetomidine and Adenotonsillectomy, run by Tanta 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 4 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 7 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. 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?
A five-point sedation score on arrival in the operating room (time frame: 30 min after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.