Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension vs ibuprofen suspension in the treatment of acute pain in children (SAPed).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507510-27-00

Acronym

SAPed

Enrollment

192

Registered

2024-01-11

Start date

Unknown

Completion date

2024-09-04

Last updated

2024-01-11

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

Conditions

Acute pain in pediatric age

Brief summary

Non inferiority of speed of action of lysin ibuprofen suspension on pain intensity measured by validated agerelated scale (Wong-Baker Faces Pain scale and Numerical Rating Scale). The reduction of pain (abbreviated PAR, from pain relief) will be assessed at different time points on the difference in the values of the pain scales used. The main assessment is at five minutes timepoint.

Detailed description

1. Evaluation of PAR general score after 10 , 20 and 30 minutes. 2. Evaluation of AEs/SAEs.

Interventions

DRUGALGIDRIN 20 mg/ml sospensione orale

DRUGBambini

DRUGMOMENTKID bambini 100 mg/5 ml sospensione orale

DRUGNUROFEN FEBBRE E DOLORE Bambini 100mg/5ml sospensione orale gusto arancia senza zucchero

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Non inferiority of speed of action of lysin ibuprofen suspension on pain intensity measured by validated agerelated scale (Wong-Baker Faces Pain scale and Numerical Rating Scale). The reduction of pain (abbreviated PAR, from pain relief) will be assessed at different time points on the difference in the values of the pain scales used. The main assessment is at five minutes timepoint.	—

Secondary

Measure	Time frame
1. Evaluation of PAR general score after 10 , 20 and 30 minutes. 2. Evaluation of AEs/SAEs.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026