Patients will receive a single intravenous (IV) infusion administered over 3 minutes of either ORG 28611 (SCH 900111), 0.12 mg/kg morphine sulphate, or placebo, within 6 hours after dental surgery, when they experience moderate to severe dental pain. Patient will then be evaluated with pain assessments at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2 through 8 hours or before rescue medication is needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
single IV dose of Org 28611 3 mcg/kg after dental impaction surgery
single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery
single IV dose of placebo after dental impaction surgery
Total Pain Relief Score (TOTPAR)
Time frame: from 0 to 4 hours
Pain Intensity (PI) on a visual analog scale (VAS), PI difference in VAS from Baseline, PI difference on a categorical scale, PI difference on categorical scale from Baseline, Pain Relief (PR) on a categorical scale, PR Intensity Difference (PRID).
Time frame: at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2 through 8 hours or before rescue medication
Time to rescue medication, time to perceptual and meaningful pain relief (stopwatch), time to onset of analgesia, Peak Pain Intensity Difference (PPID), Peak Pain Relief (PPR).
Time frame: After surgery
Global evaluation of trial medication on a 5-point categorical scale at 8 hours or just prior to rescue medication
Time frame: at 8 hours or just prior to rescue medication
TOTPAR
Time frame: over 2, 6, and 8-hour intervals
Summed pain intensity difference (SPID) calculated using PID categorical scale and PID VAS scale, Summed pain relief intensity difference (SPRID),
Time frame: Over 2, 4, 6, and 8-hour intervals
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.