SedationPhase 4NCT05821972
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
A Phase 4 study testing Nebulization of dexmedetomidine and ketamine and Nebulization of dexmedetomidine in people with Sedation and Emergence Delirium, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries. Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Sedation, Emergence Delirium
- What is being tested?
- Nebulization of dexmedetomidine and ketamine and Nebulization of dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2024to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries
Who cannot join
- Parent refusal
- Allergy to the study drugs
- Suspected difficult airway
- Patients with endocrine, renal, hepatic, and cardiac pathology
- Psychiatric diseases
- Asthmatic patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Fatma N. Mohamed, M.D., +201003633992, fatmanabil2012@aun.edu.eg
Samar A Abdellah, +201095769703
About this study
Official title: Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Read the detailed description
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.
The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
- Conditions
- Sedation, Emergence Delirium
- Being tested
- Nebulization of dexmedetomidine and ketamine, Nebulization of dexmedetomidine
- Keywords
- dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium
- Medical subject headings
- Emergence Delirium, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of dexmedetomidine and ketamineDrug
Pre-operative nebulization of dexmedetomidine and ketamine
Nebulization of dexmedetomidineDrug
Pre-operative nebulization of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Nebulized dexmedetomidine and ketamine | Experimental | Pre-operative nebulization of dexmedetomidine and ketamine Receives: Drug: Nebulization of dexmedetomidine and ketamine |
| Nebulized dexmedetomidine | Active comparator | Pre-operative nebulization of dexmedetomidine Receives: Drug: Nebulization of dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of Michigan Sedation Scale (UMSS)
It ranges from 0 = awake, alert to 4 = unarousable
Measured: Pre-operative
Secondary outcomes (2)
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.
Measured: Pre-operative
Watcha scale for emergence delirium
It ranges from 1= calm to 4 = agitated
Measured: Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start10 Apr 2024
- Primary completion20 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA NABIL AHMED MOHAMED, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821972
- Sponsor's protocol ID
- Dexmedetomidine Ketamine
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
- ClinicalTrials.gov ID
- NCT05821972
- Acronym / sponsor ID
- Dexmedetomidine Ketamine
- Conditions
- Sedation, Emergence Delirium
- Keywords
- dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 20 Apr 2023 (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.
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Detailed description
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.
The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized dexmedetomidine and ketamine | Experimental | Drug: Nebulization of dexmedetomidine and ketaminePre-operative nebulization of dexmedetomidine and ketamine |
| Nebulized dexmedetomidine | Active comparator | Drug: Nebulization of dexmedetomidinePre-operative nebulization of dexmedetomidine |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries
Key exclusion criteria (6 listed)
- Parent refusal
- Allergy to the study drugs
- Suspected difficult airway
- Patients with endocrine, renal, hepatic, and cardiac pathology
- Psychiatric diseases
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 |
|---|---|---|
| Nebulization of dexmedetomidine and ketaminePre-operative nebulization of dexmedetomidine and ketamine | Drug | Nebulized dexmedetomidine and ketamine |
| Nebulization of dexmedetomidinePre-operative nebulization of dexmedetomidine | Drug | Nebulized dexmedetomidine |
Primary outcome
University of Michigan Sedation Scale (UMSS)
Time frame: Pre-operative
It ranges from 0 = awake, alert to 4 = unarousable
2 secondary outcomes
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
Time frame: Pre-operative
Watcha scale for emergence delirium
Time frame: Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulization of dexmedetomidine and ketamine and Nebulization of dexmedetomidine in people with Sedation and Emergence Delirium, run by Assiut 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma N. Mohamed, M.D. (+201003633992, fatmanabil2012@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Michigan Sedation Scale (UMSS) (time frame: Pre-operative). 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 3 Oct 2025.