Autopsy report · NCT03063359

Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma

“The new pain protocols imposed by the HAS make it difficult to include new patients in the study”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 1 year 9 months before it stopped.
• 22 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

University Hospital, Montpellier

Sponsor type

University, hospital or other

Conditions

Pain, Acute

Interventions

Intranasal fentanyl + Oral Placebo; Oral Morphine + Intranasal Placebo

Participants

22

Sites

1

Countries

France

Trials that died the same way

• A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
  “Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements” (72% match in meaning)
• Non-pharmacological Analgesia During Heel Prick
  “The data showed that pain was higher for our standardized method of sampling” (65% match in meaning)
• Fractional Laser in Combination With UVB Therapy in Vitiligo Patients
  “Difficulty including patients” (57% match in meaning)
• Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies
  “Start of a new study concerning the same patients” (57% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.