evaluation and comparison the effectiveness of oral melatonin and midazolam as premedication on sedation and post operative complications of candidate children for dental treatment under general anesthesia with contral group

evaluation and Comparison the effectiveness of oral melatonin versus midazolam as premedication in children undergoing general anesthesia for dental treatment with contral group

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201602074224N36

Enrollment

132

Registered

2016-05-11

Start date

2016-03-19

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety. Psychotropic drugs, not elsewhere classified

Interventions

Intervention 1: group1: 40 minutes before anesthesia induction,5ml of 0.5 mg/kg oral midazolam. Intervention 2: group3:40 minutes before anesthesia induction,5ml of dextrose and water. Intervention

Treatment - Drugs

group1: 40 minutes before anesthesia induction,5ml of 0.5 mg/kg oral midazolam.

group3:40 minutes before anesthesia induction,5ml of dextrose and water

group2:40 minutes before anesthesia induction,5ml of 0.5 mg/kg oral melatonin.(maximum dosage of 20mg)

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria include:Children should be ASA1 or ASA2 (Systemic disease is confinder); Children cooperation should be in grade 1 or 2 of Frankl classification ; children should not use benzodiazepin, barbitorate or analgesics.(usage of these drugs can interfere with true effect od melatonin and midazolam); children should not have bodily or mentally disabilities; children should not have contraindication for anesthesia with propofol.6.children should not have history of convulsion exclusion criteria include:lf complications was found during operation ; If oeration takes less than 30 minutes or more than 120 minutes ; If parents are not cooperative and consont is not assigned

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Agitation. Timepoint: 20 minutes. Method of measurement: agitation scale.	—

Secondary

Measure	Time frame
Nausea. Timepoint: 24 hours. Method of measurement: nausea scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Reyhaneh Faghihian

Esfahan university of medical sciences

reyhane.fgh@gmail.com+98 31 3651 6128

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026