Separation, FamilyNCT07021755
Use Of Midazolam In Premedication Of Pediatric Patients
A study testing midazolam in people with Separation, Family and Separation Anxiety, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
: The aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Separation, Family, Separation Anxiety
- What is being tested?
- midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2009to 1 Dec 2009
- 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
- ASA I-II group
- with elective surgery planned under general anesthetic.
Who cannot join
- Patients allergic to midazolam
- rhinorrhea
- respiratory system dysfunction like nasal polyp
- neurological or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki training and research hospital
Istanbul, Fatih, 34668
About this study
Official title: Comparison Of The Effects Of Intranasal And Oral Midazolam Premedication On Sedation And Separation From Parents For Pediatric Patients
: The aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents.
Read the detailed description
Patients meeting with anesthesiologists before surgery for assessment and administration of premedication is important in terms of reducing morbidity and mortality linked to surgery and anesthesia. A study reported that 75% of children experience anxiety before surgery. This anxiety and worry observed in the pediatric patient group may cause tachycardia, hypertension and tachypnea due to increased catecholamine levels in the body and may cause aggressive reactions that are difficult to control. Additionally, it may make control of postoperative pain more difficult .
Several drugs are used before anesthesia to resolve surgical anxiety in pediatric patients and facilitate problem-free transfer to the operating room.
Midazolam is a benzodiazepine group drug, commonly used for preoperative medication for a long time. Reasons for it being chosen for premedication are that it ensure sedation and anxiolysis, has rapid onset of effect, and is more amnesic than diazepam . Though there are many routes to administer the drug, IM and IV routes are painful and frightening for patients. The premedication administration route must be acceptable for the child and not be traumatic. As a result, generally oral and intranasal routes are chosen for sedation of pediatric patients.
The aim of this study was to compare the effects of intranasal and oral midazolam, administered for premedication to preschool children, on hemodynamic parameters, sedation level and separation from parents, and in terms of complications.
The study was planned as prospective, randomized and single-blind research. After receiving permission from the ethics committee of our hospital (Haseki Clinical Research Ethics Committee No: 28.05.2009/10), the study included a total of 60 children aged 2-6 years in ASA ( Physical Status Classification System) I-II group, with elective surgery planned under general anesthetic. . Patients were allocated to two equal groups with the closed envelope method (Group O, n=30, 0.5 mg/kg oral midazolam; Group N, n=30, 0.25 mg/kg intranasal midazolam). Midazolam was administered 20 minutes before the operation. Vital signs and sedation score levels were recorded every 5 minutes. At the end of the 20th minute, the separation from parents score was assessed and recorded. Assessments were completed by an anesthesiologist who did not know the method of administration for premedication.
- Conditions
- Separation, Family, Separation Anxiety
- Being tested
- midazolam
- Keywords
- midazolam, premedication, children
- Medical subject headings
- Anxiety, Separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamOther
| Study group | Role | What they receive |
|---|---|---|
| intranasal midazolam | Experimental | Twenty minutes before anesthesia induction, the first group were given 0.25 mg/kg intranasal midazolam and named Group N (n=30). Intranasal midazolam was administered by the parent with a 2 ml injector with the needle removed, with half the dose given into one nostril and the other half into the other nostril, while the patient was lying supine. Receives: Other: midazolam |
| oral midazolam | Experimental | The second group were given 0.5 mg/kg oral midazolam and called Group O (n=30). Patients given oral midazolam drank the calculated midazolam dose mixed with 5 ml pulp-free fruit juice. Receives: Other: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation
The level of sedation was monitored every 5 minutes with the Ramsey sedation scale. Sedation scores of 1 and 2 were inadequate, while sedation scores of 3 and 4 were accepted as satisfactory
Measured: five minute
Secondary outcomes (1)
separation from parents
Twenty minutes later, separation from parents was assessed with a four-stage scale and recorded. For separation from parents, scores of 1 and 2 were satisfactory and scores of 3 and 4 were inadequate
Measured: twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jun 2009
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Separation, FamilyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ecder Ozenc, Study director, ozencecder@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021755
- Sponsor's protocol ID
- SBU-ANESTHESİA-DMY-01
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metin Yamac D, Erguven N, Ozenc E. Comparison of the Effects of Intranasal and Oral Midazolam Premedication on Sedation and Separation From Parents for Pediatric Patients. Anesthesiol Res Pract. 2026 May 13;2026:4837750. doi: 10.1155/anrp/4837750. eCollection 2026.
PubMed 42136953
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Intranasal And Oral Midazolam Premedication On Sedation And Separation From Parents For Pediatric Patients
- ClinicalTrials.gov ID
- NCT07021755
- Acronym / sponsor ID
- SBU-ANESTHESİA-DMY-01
- Conditions
- Separation, Family, Separation Anxiety
- Keywords
- midazolam, premedication, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 15 Jun 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 aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents.
Detailed description
Patients meeting with anesthesiologists before surgery for assessment and administration of premedication is important in terms of reducing morbidity and mortality linked to surgery and anesthesia. A study reported that 75% of children experience anxiety before surgery. This anxiety and worry observed in the pediatric patient group may cause tachycardia, hypertension and tachypnea due to increased catecholamine levels in the body and may cause aggressive reactions that are difficult to control. Additionally, it may make control of postoperative pain more difficult .
Several drugs are used before anesthesia to resolve surgical anxiety in pediatric patients and facilitate problem-free transfer to the operating room.
Midazolam is a benzodiazepine group drug, commonly used for preoperative medication for a long time. Reasons for it being chosen for premedication are that it ensure sedation and anxiolysis, has rapid onset of effect, and is more amnesic than diazepam . Though there are many routes to administer the drug, IM and IV routes are painful and frightening for patients. The premedication administration route must be acceptable for the child and not be traumatic. As a result, generally oral and intranasal routes are chosen for sedation of pediatric patients.
The aim of this study was to compare the effects of intranasal and oral midazolam, administered for premedication to preschool children, on hemodynamic parameters, sedation level and separation from parents, and in terms of complications.
The study was planned as prospective, randomized and single-blind research. After receiving permission from the ethics committee of our hospital (Haseki Clinical Research Ethics Committee No: 28.05.2009/10), the study included a total of 60 children aged 2-6 years in ASA ( Physical Status Classification System) I-II group, with elective surgery planned under general anesthetic. . Patients were allocated to two equal groups with the closed envelope method (Group O, n=30, 0.5 mg/kg oral midazolam; Group N, n=30, 0.25 mg/kg intranasal midazolam). Midazolam was administered 20 minutes before the operation. Vital signs and sedation score levels were recorded every 5 minutes. At the end of the 20th minute, the separation from parents score was assessed and recorded. Assessments were completed by an anesthesiologist who did not know the method of administration for premedication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal midazolam | Experimental | Other: midazolamTwenty minutes before anesthesia induction, the first group were given 0.25 mg/kg intranasal midazolam and named Group N (n=30). Intranasal midazolam was administered by the parent with a 2 ml injector with the needle removed, with half the dose given into one nostril and the other half into the other nostril, while the patient was lying supine. |
| oral midazolam | Experimental | Other: midazolamThe second group were given 0.5 mg/kg oral midazolam and called Group O (n=30). Patients given oral midazolam drank the calculated midazolam dose mixed with 5 ml pulp-free fruit juice. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I-II group
- with elective surgery planned under general anesthetic.
Key exclusion criteria (4 listed)
- Patients allergic to midazolam
- rhinorrhea
- respiratory system dysfunction like nasal polyp
- neurological or psychiatric disorder
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 |
|---|---|---|
| midazolam | Other | intranasal midazolam, oral midazolam |
Primary outcome
sedation
Time frame: five minute
The level of sedation was monitored every 5 minutes with the Ramsey sedation scale. Sedation scores of 1 and 2 were inadequate, while sedation scores of 3 and 4 were accepted as satisfactory
1 secondary outcome
separation from parents
Time frame: twenty minutes
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 15 Jun 2025.
- Derived from this study: PubMed 42136953Metin Yamac D, Erguven N, Ozenc E. Comparison of the Effects of Intranasal and Oral Midazolam Premedication on Sedation and Separation From Parents for Pediatric Patients. Anesthesiol Res Pract. 2026 May 13;2026:4837750. doi: 10.1155/anrp/4837750. eCollection 2026.
- 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.
Ecder Ozenc study director
ozencecder@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam in people with Separation, Family and Separation Anxiety, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 15 Jun 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 Turkey (Türkiye). 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?
sedation (time frame: five minute). 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 NCT07021755, which also lists 1 linked publication.
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 15 Jun 2025.