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Study of the Effect of Lidocaine-Prilocaine Cream in Pediatric Patients Undergoing Sedation for Lumbar Puncture

Study of the Efficacy of Lidocaine-Prilocaine Cream in Pediatric Patients Undergoing Lumbar Puncture with Sedation by Intravenous Anesthetics

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041250134
Enrollment
20
Registered
2025-12-02
Start date
2025-12-02
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Diseases that require lumbar puncture Lumber Puncture, Pediatric Anesthesia

Interventions

Research participants undergoing lumbar puncture will have a lidocaine-prilocaine cream applied in combination with Intravenous anesthetics.
D000077442

Sponsors

Makino Risa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following inclusion criteria will be eligible for participation: 1. Patients aged 5 to 18 years. 2. Patients who have undergone at least one lumbar puncture in the past. 3. Patients who are scheduled to undergo two or more lumbar punctures. 4. Patients from whom informed consent has been obtained, as evidenced by the signature of the patient or their legally authorized representative on the consent form.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following exclusion criteria will be excluded from the study: 1. Patients with a history of allergy to midazolam or ketamine hydrochloride. 2. Patients with a past history of contact dermatitis caused by topical medications. 3. Patients with skin abnormalities at the study drug application site that may affect observation. 4. Patients who have difficulty expressing their own intentions. 5. Patients deemed unsuitable by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Total dose of ketamine hydrochloride per body weight

Secondary

MeasureTime frame
Total dose of midazolam per body weight Presence or absence of difficult movements during lumbar puncture Presence or absence of nausea after the procedure Participant satisfaction Guardian satisfaction Adverse events

Contacts

Public ContactRisa Makino

Hamamatsu University Hospital

rmakino@hama-med.ac.jp+81-53-435-2312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026