Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery
Condition: Pain Management
Intervention: Tramadol
Intervention description: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Intervention MeSH terms: Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study evaluates the safety of IV tramadol managing post-operative pain following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female 18-75 years of age

          -  Willing to give consent and able to understand the study procedures

          -  Female patients must be of non-childbearing potential or be practicing a highly
             effective contraption

          -  The patient must be willing to be housed in a healthcare facility and able to receive
             parenteral analgesia for at least 24 hours after surgery

          -  The patient meets definition of American Society of Anesthesiologists (ASA) Physical
             Class 1, or 2.

        Exclusion Criteria:

          -  The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day
             >=3 days out of 7 days over the past 4 weeks.

          -  The patient has a recent (within 2 years) and/or current history of alcohol, opiate or
             tranquilizer abuse or dependence.

          -  The patient is taking herbal or dietary supplements or medications that are moderate
             or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline,
             quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g.,
             carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout
             period of 7 days prior to surgery.

          -  The patient has a history of epilepsy, is susceptible to seizures.

          -  The patient cannot be withdrawn from medications (at least 7 days prior to surgery)
             that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or
             which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors
             (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic
             antidepressants, triptans, amphetamines).

          -  The patient has had a recent (within 6 months) cardiovascular event or clinically
             significant abnormal ECG finding at screening.

          -  The patient has a history of Long QT Syndrome or a relative with this condition.

          -  The patient has expressed suicidal ideation within the past 3 months or is considered
             to be at risk of suicide.

          -  The patient is morbidly obese (body mass index [BMI] ≥ 40 kg/m2) or has documented
             sleep apnea requiring CPAP or other treatment.

          -  Female patient is pregnant and/or undergoing a pregnancy-related surgery, or
             breastfeeding.

          -  The patient has a history of cardiopulmonary, neurological or psychiatric condition
             that may confound the assessments of efficacy or safety.

          -  The patient has cirrhosis, moderate or severe hepatic impairment or an alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of
             normal (ULN) at Screening.

          -  The patient has severe renal impairment or a serum creatinine value of > 2x upper
             limit of normal (ULN) at Screening.

          -  The patient has potassium, sodium, calcium or magnesium levels outside of the normal
             range at Screening.

          -  The patient has a hemoglobin level at screening which, in the judgment of the
             Investigator, is not suitable for participation in this study.