A Clinical Study to evaluate Efficacy and Safety of Tapentadol Nasal Spray in Comparison to Tramadol in Patients with Post-Operative Pai
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2019/03/018143
- Lead Sponsor
- Torrent Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 294
1. Male or female subjects of 18-65 years of age, both inclusive.
2. Patient is fit for surgery under general anaesthesia or regional anaesthesia
3. Patients having physical status of I-II according to American Society of Anaesthesiologists (ASA) classification.
4. After weaning of anaesthesia post-surgery, patients having pain intensity score >= 4 on an 11-point (0 to 10) Numeric
Pain Rating Scale (NPRS).
5. Patient willing to remain hospitalized for a minimum of 5 days post-surgery.
6. Patient willing to give written informed consent to participate in the study before undergoing surgical intervention.
1. Patients with a history of hypersensitivity to Tapentadol or Tramadol.
2. History of active or suspected gastrointestinal ulcers or bleeding or motility disorder within the past 6 months prior to screening.
3. Patient who will undergo either laparoscopic surgeries (eg. laparoscopic cholecystectomy, laparoscopic appendectomy) or cardiothoracic surgeries (eg. heart bypass surgery, open esophagectomy) or cancer surgeries (eg. mastectomy).
4. Patients who have taken any medication by intranasal route within the past 72 hours prior to randomization.
5. Patients who have received analgesic postoperatively prior to
randomization.
6. Patients with chronic use of any opioids for any disease within the last 28 days prior to screening.
7. Patients currently being treated with tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, monoamine oxidase inhibitors, steroids or other drugs that has potential to reduce the seizure threshold within the past 4 weeks prior to screening.
8. Patients having clinically significant postoperative complications before randomization which may compromise safety of the patient or study outcome as per investigator opinion.
9. History of any seizure disorder or epilepsy.
10. Patients with history of mild to moderate traumatic brain injury (loss of consciousness >= 30 minutes to 6 hours), stroke or brain neoplasm within past 1-year or severe traumatic brain injury (loss of consciousness >= 6 hours) within past 15
years prior to screening.
11. Patients with clinically significant ECG abnormalities or QTc >= 450 msec for male or QT >= 470 msec for female at screening.
12. Any clinically significant abnormal nasal or respiratory tract conditions i.e., atrophic rhinitis, nasal polyp, upper respiratory tract infection etc. which can interfere with the absorption of the drug.
13. History of drug abuse or known active alcohol abuse within past 6 months.
14. Patients with liver enzymes (Alanine transaminase, Aspartate transaminase, Alkaline phosphatase) > 2.5X the upper limit of normal value (ULN) or total bilirubin >1.5X of ULN or serum creatinine >1.5X of ULN at screening.
15. Patients having respiratory rate less than 12 breaths per minute or greater than 20 breaths per minute at randomization.
16. History of active Hepatitis B or Hepatitis C or HIV infection.
17. Pregnant or lactating women.
18. In the opinion of the investigator, patient is either unable to cooperate or unlikely to adhere with any study procedures.
19. Patients who have participated in any other investigational drug trial within the past four weeks prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain intensity difference <br/ ><br>2. Patient Global Assessment <br/ ><br>3. Sum of Pain Intensity DifferenceTimepoint: 1. Pain intensity difference at 60 minutes <br/ ><br>2. Patient Global Assessment at 24 hours <br/ ><br>3. Sum of Pain Intensity Difference at 60 minutes
- Secondary Outcome Measures
Name Time Method 1. Sum of Pain Intensity Difference <br/ ><br>2. Meaningful pain relief <br/ ><br>3. Total pain relief score <br/ ><br>4. First intake of rescue medication for pain <br/ ><br>5. Percentage of patients who required rescue medication for nausea and <br/ ><br>vomiting <br/ ><br>6. Pain intensity difference <br/ ><br>7. Patient global assessmentTimepoint: 1. Sum of Pain Intensity Difference at 2 hrs, 4 hrs, 24 hrs, 48 hrs, 72 hrs, <br/ ><br>96 hrs and 120 hours <br/ ><br>2. Median Time to onset of meaningful pain relief <br/ ><br>3. Total pain relief score at at 24 hrs, 48 hrs, 72 hrs, 96 hrs and 120 <br/ ><br>4. Median time to first intake of rescue medication for pain <br/ ><br>5. NA <br/ ><br>6. Pain intensity difference at pre-2nd dose and pre-3rd dose <br/ ><br>7. Patient global assessment at 120 hours