Autopsy report · NCT01576432

Non-pharmacological Analgesia During Heel Prick

“The data showed that pain was higher for our standardized method of sampling”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 3 months after it had already started.
• Ran for about 1 year 3 months before it stopped.
• 136 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Puerta de Hierro University Hospital

Sponsor type

University, hospital or other

Conditions

Pain; Breastfeeding

Interventions

Assess pain with the NIPS score

Participants

136

Sites

1

Countries

Spain

Trials that died the same way

• 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” (65% match in meaning)
• 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” (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.