Moderate to Severe Acute Post Operative Pain Classification code 10036286
Conditions
Interventions
Product Name: M6G
Product Code: M6G
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pending
CAS Number: 20290-10-2
Sponsors
CeNeS Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing any of the following elective procedures that would be expected to require PCA for up to 48 hours (minimum 24 hours) for relief of moderate to severe post-operative pain. 1) Abdominal hysterectomy with the exception of laparoscopic procedures 2) Bowel / GI surgery 3) Major urological surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy or lactation. 2) Known sensitivity to morphine or other opiates, or a medical condition such that opiates are contraindicated. 3) Known sensitivity to paracetamol, or a medical condition such that paracetamol is contraindicated. 4) Blood clotting disorder or other blood dyscrasias. 5) History of Left Ventricular Failure or compromised cardiovascular function, defined as NYHA level 3. 6) History of severe renal impairment or a creatinine level >3 times the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Pain relief over the 24 hour post-operative period Incidence and severity of nausea ;Main Objective: To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hours post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.; Secondary Objective: To compare the analgesic effect of the study treatments. To compare the incidence and severity of nausea and vomiting in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours. To compare the amounts of study drug required to achieve a baseline pain severity score of = 3. To compare the total consumption of study drugs (loading dose, plus dose to achieve the baseline pain level, plus the amounts given by PCA and PCA rescue. To compare the patients; overall opinions of the study treatments. To compare the safety of the study treatments. To compare the use of anti-emetic medication. | — |
Countries
Czech Republic, Germany, Hungary, Spain, United Kingdom
Outcome results
None listed