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 childre

Phase 2

• Conditions: Other disorders of central nervous system.; Other disorders of central nervous system; G90-G99

• Registration Number: IRCT201609222639N19
• Lead Sponsor: Shahid Sadoughi University of Medical Sciences, Yazd, Iran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.