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

ConditionLimb Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morphine

    Drug

    oral morphine (0.5 mg / kg)

  • IN fentanyl

    Drug

    IN fentanyl (1.5 µg/kg)

  • IN ketamine

    Drug

    IN ketamine (1 mg/kg)

  • NaCl 0,9 %

    Drug

    Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: MorphineActive comparator 2 interventions
Group B: IN FentanylExperimental treatment 2 interventions
Group C: IN KetaminExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Degree of pain (M30)

Success: children \<7 years with a pain score assessed by Evendol \< 5 years, 30 minutes after drugs administration, without rescue analgesia. Scale: 0-15 (no pain - painful)

Time frame
30 minutes
2

Degree of pain (M30)

Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia. Visual Analog Scale : 0-100 (no pain- painful)

Time frame
30 minutes

Secondary outcomes

1

Degree of pain (M15)

Success: children \<7 years with a pain score assessed by Evendol \< 5, 15 minutes after drugs administration, without rescue analgesia

Time frame
15 minutes
2

Degree of pain (M15)

Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 15 minutes after drugs administration, without rescue analgesia

Time frame
15 minutes
3

Degree of pain (M60)

Success: children \<7 years with a pain score assessed by Evendol \< 5, 60 minutes after drugs administration, without rescue analgesia

Time frame
60 minutes
4

Degree of pain (M60)

Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 60 minutes after drugs administration, without rescue analgesia

Time frame
60 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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