Effect of intranasal midazolam with topical lidocaine ointment on the success of blood draw and cerebrospinal fluid retrieval

Comparison of the effect of intranasal midazolam with topical lidocaine ointment with intranasal midazolam alone on the success of blood draw and cerebrospinal fluid retrieval

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151003024317N13

Enrollment

Registered

2022-01-19

Start date

2022-02-04

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Cerebrospinal fluid retrieval. Cerebrospinal fluid leak from spinal puncture

Interventions

Intervention 1: Intervention group: children will receive intranasal midazolam with lidocaine ointment topically in the process of blood sampling and cerebrospinal fluid collection, and each person wi

Eligibility

Sex/Gender

All

Age

1 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children over 1 year Suffering from a variety of neurological and infectious diseases

Exclusion criteria

Exclusion criteria: Children over 7 years Weight less than 10 kg Decreased level of consciousness Underlying neurological impairment Use of analgesics 12 hours before puncture Acute or chronic respiratory, renal, and hepatic disorders

Design outcomes

Primary

Measure	Time frame
Respiratory disorders. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;The amount of pain. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;Percentage of oxygen saturation. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.	—

Measure

Time frame

Respiratory disorders. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;The amount of pain. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;Percentage of oxygen saturation. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.

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Secondary

Measure	Time frame
Heart rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;Respiratory rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.	—

Measure

Time frame

Heart rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.;Respiratory rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShaqayeq Khosravi

Iran University of Medical Sciences

shaqayeq.khosravi@gmail.com009886701

Outcome results

None listed

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