Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia Californica per os and placebo in patients undergoing dental surgery over an observation period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)
Time frame: Baseline, up to 6 hours after drug intake
Pain intensity differences (PID) on a VAS
Time frame: Baseline, up to 6 hours after drug intake
Pain intensity difference in the groups on a VAS
Time frame: Baseline, 2 hours after drug intake
Time point for maximum pain intensity difference on VAS
Time frame: Baseline, up to 6 hours after drug intake
Number of patients with a pain decrease of at least 50 % over the all period of observation on a VAS
Time frame: Baseline, up to 6 hours after drug intake
Pain relief at each observed time points on a 5-point verbal rating scale (VRS)
Time frame: up to 6 hours after drug intake
Total pain relief on a 5-point VRS
Time frame: up to 6 hours after drug intake
Global efficacy assessment on a 4-points VRS
Time frame: 2 and 6 hours after drug intake, day 7
Number of patients requiring a rescue medication
Time frame: Day 1
Number of patients with adverse events
Time frame: up to 9 days after treatment
Assessment of tolerability by investigator on a 4-point VRS
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Time frame: 6 hours after drug intake, day 7
Assessment of tolerability by subject on a 4-point VRS
Time frame: 6 hours after drug intake, day 7