A randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
DanTrials
Copenhagen, NV, Denmark
Sum of pain intensity differences at 55 min
Derived from pain intensity scores measured by the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible pain).
Time frame: 0-55 min
PK-PD relationship for analgesic efficacy IN sufentanil, IN ketamine and IN CT001
To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.
Time frame: 0-180 min
Maximum Pain intensity difference (PIDmax)
Time frame: 0-180 min
Time to meaningful pain relief
Time when participants feel that the pain relief becomes meaningful to them
Time frame: 0-180 min
Sum of pain intensity differences at 30 min
Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
Time frame: 0-30 min
Rescue medication
Number of participants receiving rescue medication
Time frame: 0-180 min
Number of patients who are considered a responder/non-responder, 30%
Number of participants with at least 30% reduction in pain intensity score compared to baseline
Time frame: 0-30 min
Number of patients who are considered a responder/non-responder, 50%
Participants with at least at least 50% reduction in pain intensity score compared to baseline
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Intranasal
Time frame: 0-30 min
Sum of pain intensity differences at 90 min
Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
Time frame: 0-90 min
Time to perceptible pain relief
Time when participants feel that the pain relief becomes meaningful to them
Time frame: 0-180 min
Time to rescue medication
Time frame: 0-180 min
Mean pain intensity difference (PID) from baseline at rest
Time frame: 0-180 min
Mean pain intensity difference (PID) from baseline on jaw movement
Time frame: 0-181 min
Ramsay sedation score
Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
Time frame: 0-179 min
Median time to a request for rescue medication
Time frame: 0-180 min