Clinical trial of efficacy evaluation of midazolam alone and midazolam with maternal presence on reduction of pain and anxiety of lumbar puncture of 6-24 month old children

Efficacy of midazolam alone and midazolam with maternal presence in lumbar puncture of 6-24 month old children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201609222639N19

Enrollment

Registered

2016-10-01

Start date

2015-03-21

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

Other disorders of central nervous system. Other disorders of central nervous system

Interventions

Intervention 1: 0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and mother will be out of the room during lumbar punc

0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and mother will be out of the room during lumbar puncture of her chil

0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and during lumbar puncture of the child, mother will be in the room a

Eligibility

Sex/Gender

All

Age

6 Months to 2 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age range of 6-24 months; undergone lumbar puncture based on clinical judgment of the pediatrician; not received sedative hypnotic drugs within the past 48 hours Exclusion criteria: Neurodevelopmental delay or mental retardation; loss of consciousness (Glasgow coma scale less than 12); symptoms of increased intracranial pressure; done lumbar puncture more than two times; previously undergone lumbar puncture

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Anxiety score before skin needle insertion for lumbar puncture. Timepoint: Before skin needle insertion for lumbar puncture. Method of measurement: Questionnaire.;Pain score during needle insertion to skin. Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Success rate in reducing of anxiety during skin needle insertion (anxiety score of four and more three). Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.;Success rate in reducing of pain (pain score of less than three). Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Farzad Ferdosian

Shahid Sadoughi University of Medical Sciences, Yazd, Iran

ferdosianfarzad@yahoo.com+98 35 3822 4000

Outcome results

None listed

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