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A randomized, double-blind parallel group study to investigate propofol injection pain compared with placebo in healthy adult male and female participants. (PropPain)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514307-34-01
Enrollment
96
Registered
2025-04-01
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

• Proportion of participants with VAS≥30 mm (0-100mm)

Detailed description

• • Max electronic Visual Analog Scale (VAS) pain (0-100 mm), • Max Numeric Rating Scale (NRS) pain (0-10), • Time (seconds) to max electronic Visual Analog Scale (VAS) pain, • Area under the curve (AUC) 0-1 min, 1-2 min, 2-3 min, • Area under the curve VAS≥30 (AUCVAS≥30) 0-1 min, 1-2 min, 2-3 min, • Curve shape of electronic Visual Analog Scale (VAS) pain (0-100 mm) by description of the curve (number of peaks), • Max Numeric Rating Scale (NRS) pain (0-10), • Richmond Agitation-Sedation Scale (RASS)

Interventions

DRUGPropolipid 10 mg/ml injeksjons-/infusjonsvæske
DRUGSALINE

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
• Proportion of participants with VAS≥30 mm (0-100mm)

Secondary

MeasureTime frame
• • Max electronic Visual Analog Scale (VAS) pain (0-100 mm), • Max Numeric Rating Scale (NRS) pain (0-10), • Time (seconds) to max electronic Visual Analog Scale (VAS) pain, • Area under the curve (AUC) 0-1 min, 1-2 min, 2-3 min, • Area under the curve VAS≥30 (AUCVAS≥30) 0-1 min, 1-2 min, 2-3 min, • Curve shape of electronic Visual Analog Scale (VAS) pain (0-100 mm) by description of the curve (number of peaks), • Max Numeric Rating Scale (NRS) pain (0-10), • Richmond Agitation-Sedation Scale (RASS)

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026