RecruitingPhase 3ketamine

Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine

Sponsored by Assistance Publique - Hôpitaux de Paris

NCT ID
NCT06464146
Target Enrollment
300 participants
Start Date
2025-02-26
Est. Completion
2028-02

About This Study

The purpose of this study is 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.

Conditions Studied

Limb Injury

Interventions

  • Morphine
  • IN fentanyl
  • IN ketamine
  • NaCl 0,9 %

Eligibility

Age:2 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Child aged 2 years to 17 years and 11 months
* With 10 kg ≤ Weight ≤ 100 kg
* 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)
* Within the first 12 hours after the injury
* VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child \< 7 years)
* Affiliated to health insurance
* At least one signed parental informed consent

Exclusion Criteria:

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

Study Locations (5)

Ambroise Paré Hospital
Boulogne-Billancourt, France
Roger Salengro Hospital
Lille, France
Timone Hospital
Marseille, France
Mère-Enfant Hospital
Nantes, France
Hopital Necker Enfants malades
Paris, France

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Hélène CHAPPUY, MD, PhD
CONTACT
+33 1 44 49 41 26helene.chappuy@aphp.fr
Nelly BRIAND, PhD
CONTACT
0144381862nelly.briand@aphp.fr
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source