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AntaMIn - Pain reduction for limb injuries in pediatric emergency departments: A Randomised Clinical Trial comparing intranasal Fentanyl or intranasal Ketamine to oral morphine

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506803-25-01
Acronym
APHP211044
Enrollment
300
Registered
2024-05-28
Start date
2025-02-26
Completion date
Unknown
Last updated
2025-11-26

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

Conditions

limb injuries, urgency

Brief summary

Success: children <7 years with a pain score assessed by Evendol < 5 or children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia -Failure: Evendol ≥ 5 or VAS > 30, 30 minutes after drugs administration or need for rescue analgesia during the first 30 minutes after drugs administration

Detailed description

Success pain evaluation (success as defined in primary outcome) during the first 2 hours after drugs administration, at 15 (M15), 60 (M60), 90 (M90) and 120 minutes (M120), Reduction in pain scores from baseline at M15, M30, M60, M90 and M120, Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) at 5, 10, 15, 30, 60, 90 and 120 minutes after drugs administration., - Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure)., General satisfaction of parents and patient ≥ 7 years old on a scale of 0–100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) at ED discharge

Interventions

DRUGMORPHINE SULFATE
DRUGKETAMINE
DRUGFENTANYL CITRATE
DRUGSODIUM CHLORIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Success: children <7 years with a pain score assessed by Evendol < 5 or children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia -Failure: Evendol ≥ 5 or VAS > 30, 30 minutes after drugs administration or need for rescue analgesia during the first 30 minutes after drugs administration

Secondary

MeasureTime frame
Success pain evaluation (success as defined in primary outcome) during the first 2 hours after drugs administration, at 15 (M15), 60 (M60), 90 (M90) and 120 minutes (M120), Reduction in pain scores from baseline at M15, M30, M60, M90 and M120, Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) at 5, 10, 15, 30, 60, 90 and 120 minutes after drugs administration., - Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure)., General satisfaction of parents and patient ≥ 7 years old on a scale of 0–100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) at ED discharge

Countries

France

Outcome results

None listed

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