Propofol for Pain

Inclusion criteria

• {"criterion_text":"- 1.\tThe participant is overtly healthy as determined by medical evaluation including medical history and physical examination\n- 2.\tParticipant is ≥ 18 and < 50 years of age\n- 3.\tHighly sensitive urine pregnancy test is negative for WOCBP\n- 4.\tThe 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"}

Exclusion criteria

• {"criterion_text":"- 1.\tKnown allergy or intolerance to the study intervention propofol\n- 10.\tKnown neurological illnesses (eg epilepsy)\n- 2.\tKnown allergy or intolerance to eggs, soya or peanuts\n- 3.\tBMI is <16 and ≥30\n- 4.\tUse of analgesics or alcohol the last 24 h before study intervention\n- 5.\tThe participant is breastfeeding\n- 6.\tThe participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)\n- 7.\tParticipation in other clinical studies within the last two months before study intervention\n- 8.\tNot meeting the rules of fasting according to the protocol\n- 9.\tAny condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures."}

Primary endpoints

• {"endpoint_text":"- \tProportion of participants with VAS≥30 mm (0-100mm)","definition_or_measurement_approach":"Measured using electronic Visual Analog Scale (VAS) 0-100 mm; endpoint is proportion of participants with VAS score ≥30 mm."}

Secondary endpoints

• {"endpoint_text":"- \t•\tMax electronic Visual Analog Scale (VAS) pain (0-100 mm)\n- \t•\tMax Numeric Rating Scale (NRS) pain (0-10)\n- \t•\tTime (seconds) to max electronic Visual Analog Scale (VAS) pain\n- \t•\tArea under the curve (AUC) 0-1\tmin, 1-2 min, 2-3 min\n- \t•\tArea under the curve VAS≥30 (AUCVAS≥30) 0-1 min, 1-2 min, 2-3 min\n- \t•\tCurve shape of electronic Visual Analog Scale (VAS) pain (0-100 mm) by description of the curve (number of peaks)\n- \t•\tMax Numeric Rating Scale (NRS) pain (0-10)\n- \t•\tRichmond Agitation-Sedation Scale (RASS)","definition_or_measurement_approach":"Max electronic VAS pain: maximum value on electronic VAS (0-100 mm). Max NRS pain: maximum value on Numeric Rating Scale (0-10). Time to max VAS: measured in seconds from injection to peak VAS. AUC measures: area under VAS curve for specified minute intervals (0-1, 1-2, 2-3 min). AUC VAS≥30: AUC for periods where VAS≥30. Curve shape: descriptive analysis of VAS curve (number of peaks). RASS: Richmond Agitation-Sedation Scale used to assess sedation."}

Norway

Earliest CTIS Part Ii Submission Date

17-03-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

235

Number Of Sites

1

Number Of Participants

96

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway