PROPOFOL for Pain|Propofol injection pain

Inclusion criteria

• {"criterion_text":"- The participant is overtly healthy as determined by medical evaluation including medical history and physical examination"}
• {"criterion_text":"- Participant is ≥ 18 and < 50 years of age"}
• {"criterion_text":"- Highly sensitive urine pregnancy test is negative for WOCBP"}
• {"criterion_text":"- The participant must give a signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol"}
• {"criterion_text":"- The participant has participated in the PropPain study (EU CT 2024-514307-34-01) and obtained a max electronic Visual Analog Scale (VAS) pain ≥30 mm"}

Exclusion criteria

• {"criterion_text":"- Known allergy or intolerance to the study intervention icatibant, or to propofol"}
• {"criterion_text":"- Any condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures."}
• {"criterion_text":"- Known allergy or intolerance to eggs, soya or peanuts"}
• {"criterion_text":"- Known neurological illness (e.g. epilepsy)"}
• {"criterion_text":"- BMI is <16 and ≥30"}
• {"criterion_text":"- Use of analgesics or alcohol the last 24 h before the study interventions"}
• {"criterion_text":"- The participant is breastfeeding"}
• {"criterion_text":"- The participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)"}
• {"criterion_text":"- Participation in other clinical studies within the last two months before study intervention (except the related study mentioned above)"}
• {"criterion_text":"- Not meeting the rules of fasting according to the protocol"}

Primary endpoints

• {"endpoint_text":"- Area under the curve of Visual Analog Scale pain ≥ 30 mm (0-100 mm) - AUCVAS≥30","definition_or_measurement_approach":"Area under the curve of electronic Visual Analog Scale pain scores (0-100 mm) for events with pain ≥30 mm (AUC of VAS scores)."}

Secondary endpoints

• {"endpoint_text":"- Max electronic Visual Analog Scale (VAS) pain (0-100 mm)","definition_or_measurement_approach":"Maximum recorded electronic Visual Analog Scale pain score (0-100 mm)."}

Norway

Earliest CTIS Part Ii Submission Date

21-07-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

24

Number Of Sites

1

Number Of Participants

26

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"University of Oslo, Institute of Clinical Medicine, Faculty of Medicine","duties_or_roles":"Source of monetary support","organisation_type":"University / Academic institution"}
• {"country":"Norway","full_name":"Dept. of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Norway","duties_or_roles":"Source of monetary support","organisation_type":"Hospital department"}