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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

26 Feb 2025 → ongoing

Decision date (initial)

2024-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS _ ministère de la santé _ PHRC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine if IN fentanyl (1.5 µg / kg) or IN ketamine (1 mg / kg) is more effective at 30 minutes than oral morphine (0.5 mg / kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

Secondary objectives 4

1. To determine if IN fentanyl or IN ketamine is more effective at 15, 60, 90 and 120 min than oral morphine in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.
2. To compare the pain score reduction from baseline to 30 minutes between IN ketamine and IN fentanyl
3. To assess the tolerance of oral morphine, IN fentanyl and IN ketamine.
4. To assess the satisfaction from parents and patients >7 years aged about analgesia

Conditions and MedDRA coding

urgency

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1) Child aged 2 years to 17 years and 11 months
2. With 10 kg ≤ Weight ≤ 100 kg
3. Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and / or functional impotence in the injured limb(s)
4. Within the first 12 hours after the injury
5. VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7) or Evendol pain score at ED arrival ≥ 7/15 (if child <7 years)
6. Affiliated to health insurance
7. At least one signed parental informed consent

Exclusion criteria 16

1. Received narcotic pain medication prior to arrival
2. History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, , hepatocellular insufficiency
3. Active or history of psychiatric disorder
4. Known pregnancy or suspicion of being pregnant
5. Breastfeeding
6. Non-French speaking parent and / or child.
7. Participation to another interventional clinical research
8. Contraindication to morphine, mentioned in SmPC
9. Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.
10. Contraindication to fentanyl or ketamine, mentioned in SmPC
11. GCS <15
12. Evidence of significant femur, head, chest, abdominal, or spine injury
13. Open fracture
14. Nasal trauma or complete nasal obstruction
15. Active epistaxis
16. Nasal or sinus surgery within 6 months before inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 5

1. 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)
2. Reduction in pain scores from baseline at M15, M30, M60, M90 and M120
3. 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.
4. - 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).
5. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Hélène CHAPPUY

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Hélène CHAPPUY

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications