An interventional study of midazolam in Separation, Family and Separation Anxiety, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Other
: 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.
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.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 60 is below the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
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Inclusion Criteria: - Children 2-6 years old
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: midazolam
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.
Other: midazolam
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
Time frame: five minute
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
Time frame: twenty minutes
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey →