Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Sep 20, 2023

Keywords

ClinConnect Summary

The FORE-PAIN trial is studying the effectiveness and safety of two pain relief medications, fentanyl and esketamine, for people experiencing severe pain from trauma. Both medications are commonly used in emergency situations, but it's not clear if they work equally well or if the way they are given (through the nose or through an IV) makes a difference. In this trial, some participants will receive fentanyl through an IV, while others will receive esketamine either through an IV or through the nose, to see if they all provide similar pain relief and have similar safety profiles.

To be eligible for this trial, participants must be at least 18 years old and have experienced trauma on the same day that requires strong pain relief. They must also be able to communicate their pain levels and be able to receive the medication properly. However, those with certain health conditions, significant weight issues, or who have previously opted out of research will not be able to participate. If you join the study, you can expect to receive one of the medications while being monitored for your pain and safety, helping researchers learn more about the best ways to manage trauma-related pain in emergency settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age ≥ 18 years
• • pain has been caused by a trauma (any trauma mechanism) that occurred on the same day
• • Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required
• • patient will be transported to a hospital
• Exclusion Criteria:
• • (estimated) weight \<40 or \>100 kg
• • subject does not understand Dutch or English
• • inability to report pain score
• • inability to give IN or IV medication
• • known severe cardiovascular disease
• • pre-eclampsia
• • Glasgow Coma Scale score \< 11
• • subject is known to have previously declined participation in medical research