Preoperative Anxiety Experienced by the Pediatric PatientPhase 2NCT06979791
Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery
A Phase 2 study testing Dexmedetomidine + Midazolam 0.4 mg/kg and Dexmedetomidine + Midazolam 0.2 mg/kg in people with Preoperative Anxiety Experienced by the Pediatric Patient and Preoperative Anxiety, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Preoperative Anxiety Experienced by the Pediatric Patient, Preoperative Anxiety
- What is being tested?
- Dexmedetomidine + Midazolam 0.4 mg/kg and Dexmedetomidine + Midazolam 0.2 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Phase 2
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1 to 8 years
- Scheduled for elective surgery under general anesthesia
- Surgery duration < 1 hour
- ASA physical status I or II
- Parent or legal guardian able to provide informed consent
Who cannot join
- Refusal to participate by parent/guardian
- Nasal infections, pathology, or epistaxis
- Runny nose or upper respiratory tract infection
- Hepatic Dysfunction or significant liver disease
- Epilepsy
- BMI > 30
Show all 13Show fewer
- Known allergy to dexmedetomidine or midazolam
- Fever on day of surgery
- Coagulopathy
- Scheduled for cardiothoracic or neurosurgical procedures
- Congenital heart disease
- Neurological or mental disorders
- Pre-existing sedation (MOASS < 5) on the day of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:
Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?
Read more
How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?
Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.
Participants will:
Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.
Undergo sedation scoring at 15 and 30 minutes after drug administration.
Be assessed for ease of separation from parents and acceptance of anesthesia mask.
Be monitored for vital signs, recovery times, and any perioperative adverse events.
- Being tested
- Dexmedetomidine + Midazolam 0.4 mg/kg, Dexmedetomidine + Midazolam 0.2 mg/kg
- Keywords
- premedication, intranasal dexmedetomidine, intranasal midazolam, sedation, mask acceptance, Pediatric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine + Midazolam 0.4 mg/kgDrug
Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.
Dexmedetomidine + Midazolam 0.2 mg/kgDrug
Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine + Midazolam 0.4 mg/kg | Experimental | Not described Receives: Drug: Dexmedetomidine + Midazolam 0.4 mg/kg |
| Dexmedetomidine + Midazolam 0.2 mg/kg | Experimental | Not described Receives: Drug: Dexmedetomidine + Midazolam 0.2 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask Acceptance Score (MAS) at time of induction
Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.
Measured: At the time of induction (approximately 30 minutes after premedication)
Secondary outcomes (7)
Sedation Level (MOASS) at 15 and 30 minutes after premedication
Sedation will be evaluated using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS). Scores will be recorded at 15 and 30 minutes after intranasal drug administration.
Measured: 15 minutes and 30 minutes after drug administration
Child-Parent Separation Score
Measured using the Child-Parent Separation Scale at the time of separation from parents. Scores of 1 or 2 indicate satisfactory separation; score of 3 indicates poor separation.
Measured: Approximately 30 minutes after premedication (at time of separation)
Heart Rate
Heart rate will be monitored at baseline, 30minutes after medication and at the time of anesthesia induction. Mean heart rate values will be compared between the two groups.
Measured: Baseline, 30minutes after medication and at the time of anesthesia induction.
Blood Pressure
Mean blood pressure will be monitored at baseline, 30minutes after medication and at the time of anesthesia induction. Mean blood pressure values will be compared between the two groups.
Measured: Baseline, 30minutes after medication and at the time of anesthesia induction.
Time to Recovery (Modified Aldrete Score ≥ 9)
The time from cessation of inhalational anaesthesia to achieving a Modified Aldrete Score of ≥9 will be recorded.
Measured: From cessation of inhalational anaesthesia until Modified Aldrete Score ≥9 is achieved.
Time to Extubation
The time from the cessation of inhalational anesthesia and the removal of the endotracheal tube will be recorded.
Measured: The time between the cessation of inhalational anesthesia and the removal of the endotracheal tube.
Perioperative Adverse Events
Incidence of adverse effects such as nasal irritation, Post Operative nausea\& vomiting will be recorded and compared between groups.
Measured: From the time of drug administration until discharge from the Post-Anesthesia Care Unit (PACU) to the Ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preoperative Anxiety Experienced by the Pediatric PatientStudies of the same condition, open and under way.
- More trials run by Cairo 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two treatment arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed AbdElaty Hamed Ellhwany, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979791
- Sponsor's protocol ID
- MD-394-2024
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mountain BW, Smithson L, Cramolini M, Wyatt TH, Newman M. Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA J. 2011 Jun;79(3):219-24.
PubMed 21751690Cohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. doi: 10.1053/j.gastro.2007.06.002. No abstract available.
PubMed 17681185Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
PubMed 10702460Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.
PubMed 14616431Dhiman T, Verma V, Kumar Verma R, Rana S, Singh J, Badhan I. Dexmedetomidine-Ketamine or Dexmedetomidine-Midazolam Nebulised Drug Combination as a Premedicant in Children: A Randomised Clinical Trial. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):380-387. doi: 10.5152/TJAR.2022.21298.
PubMed 36301288Gomez-Manzano FJ, Laredo-Aguilera JA, Cobo-Cuenca AI, Rabanales-Sotos J, Rodriguez-Canamero S, Martin-Espinosa N, Carmona-Torres JM. Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review. Children (Basel). 2022 Apr 29;9(5):644. doi: 10.3390/children9050644.
PubMed 35626821
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06979791
- Acronym / sponsor ID
- MD-394-2024
- Keywords
- premedication, intranasal dexmedetomidine, intranasal midazolam, sedation, mask acceptance, Pediatric anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 20 May 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.
The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:
Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?
How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?
Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.
Participants will:
Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.
Undergo sedation scoring at 15 and 30 minutes after drug administration.
Be assessed for ease of separation from parents and acceptance of anesthesia mask.
Be monitored for vital signs, recovery times, and any perioperative adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine + Midazolam 0.4 mg/kg | Experimental | Drug: Dexmedetomidine + Midazolam 0.4 mg/kg |
| Dexmedetomidine + Midazolam 0.2 mg/kg | Experimental | Drug: Dexmedetomidine + Midazolam 0.2 mg/kg |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients aged 1 to 8 years
- Scheduled for elective surgery under general anesthesia
- Surgery duration < 1 hour
- ASA physical status I or II
- Parent or legal guardian able to provide informed consent
Key exclusion criteria (13 listed)
- Refusal to participate by parent/guardian
- Nasal infections, pathology, or epistaxis
- Runny nose or upper respiratory tract infection
- Hepatic Dysfunction or significant liver disease
- Epilepsy
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 |
|---|---|---|
| Dexmedetomidine + Midazolam 0.4 mg/kgParticipants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia. | Drug | Dexmedetomidine + Midazolam 0.4 mg/kg |
| Dexmedetomidine + Midazolam 0.2 mg/kgParticipants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia. | Drug | Dexmedetomidine + Midazolam 0.2 mg/kg |
Primary outcome
Mask Acceptance Score (MAS) at time of induction
Time frame: At the time of induction (approximately 30 minutes after premedication)
Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.
7 secondary outcomes
Sedation Level (MOASS) at 15 and 30 minutes after premedication
Time frame: 15 minutes and 30 minutes after drug administration
Child-Parent Separation Score
Time frame: Approximately 30 minutes after premedication (at time of separation)
Heart Rate
Time frame: Baseline, 30minutes after medication and at the time of anesthesia induction.
Blood Pressure
Time frame: Baseline, 30minutes after medication and at the time of anesthesia induction.
Time to Recovery (Modified Aldrete Score ≥ 9)
Time frame: From cessation of inhalational anaesthesia until Modified Aldrete Score ≥9 is achieved.
Time to Extubation
Time frame: The time between the cessation of inhalational anesthesia and the removal of the endotracheal tube.
Perioperative Adverse Events
Time frame: From the time of drug administration until discharge from the Post-Anesthesia Care Unit (PACU) to the Ward
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 17 Sep 2026.
- Background: PubMed 21751690Mountain BW, Smithson L, Cramolini M, Wyatt TH, Newman M. Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA J. 2011 Jun;79(3):219-24.
- Background: PubMed 17681185Cohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. doi: 10.1053/j.gastro.2007.06.002. No abstract available.
- Background: PubMed 10702460Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
- Background: PubMed 14616431Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.
- Background: PubMed 36301288Dhiman T, Verma V, Kumar Verma R, Rana S, Singh J, Badhan I. Dexmedetomidine-Ketamine or Dexmedetomidine-Midazolam Nebulised Drug Combination as a Premedicant in Children: A Randomised Clinical Trial. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):380-387. doi: 10.5152/TJAR.2022.21298.
- Background: PubMed 35626821Gomez-Manzano FJ, Laredo-Aguilera JA, Cobo-Cuenca AI, Rabanales-Sotos J, Rodriguez-Canamero S, Martin-Espinosa N, Carmona-Torres JM. Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review. Children (Basel). 2022 Apr 29;9(5):644. doi: 10.3390/children9050644.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Dexmedetomidine + Midazolam 0.4 mg/kg and Dexmedetomidine + Midazolam 0.2 mg/kg in people with Preoperative Anxiety Experienced by the Pediatric Patient and Preoperative Anxiety, run by Cairo 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 5 inclusion and 13 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 17 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mask Acceptance Score (MAS) at time of induction (time frame: At the time of induction (approximately 30 minutes after premedication)). 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 NCT06979791, which also lists 6 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 17 Sep 2026.