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| Name | Class |
|---|---|
| The Third Xiangya Hospital of Central South University | OTHER |
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The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meloxicam injection 30 mg | Experimental | meloxicam injection 30mg every 24 hours for up to 2 doses. |
|
| meloxicam injection 60 mg | Experimental | meloxicam injection 60mg every 24 hours for up to 2 doses |
|
| IV Placebo | Placebo Comparator | IV Placebo every 24 hours for up to 2 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Injection 30mg | Drug | meloxicam injection 30mg every 24 hours for up to 2 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference Over the First 24 Hours (SPID24) | Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference (SPID) at Other Intervals | Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better. |
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Inclusion Criteria:
Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.
Be American Society of Anesthesiology (ASA) physical class 1 or 2. Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18~30 kg/m2. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Exclusion Criteria:
Have a history of abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.
Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
Have another painful physical condition that may confound the assessments of post operative pain.
Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.
Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.
Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yangwen ou, medical doctor | Contact | 0731-88618151 | ouyangwen139@126.com | |
| saiying wang, medical doctor | Contact | 0731-88618150 | 1771303488@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third XiangYa Medical Hospital of Central South University | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Meloxicam Injection 60mg | Drug | meloxicam injection 60mg every 24 hours for up to 2 dose |
|
| Nacl 0.9% | Drug | IV Placebo every 24 hours for up to 2 doses |
|
| 48 Hours |
| Time to First Dose of Rescue Analgesia | Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. | 48 Hours |
| Number of Subjects Utilizing Rescue Analgesia | Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. | 48 Hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |