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Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Intravenous tramadol 50mg + intravenous metoclopramide 10mg |
|
| Group 2 | Active Comparator | Intravenous tramadol 50mg + placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | One dose of intravenous tramadol 50mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea severity scale | Change in rating of nausea severity on Visual Analogue Scale 60 minutes after administration of the study drugs. VAS is a standard 100mm line marked "no nausea" at the left end and "worst nausea imaginable" at the right end. Minimum clinically significant difference is defined for this study as 20 mm increment. | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| Vomiting | Number of episodes of vomiting 60 minutes after administration of study drugs | One hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarawak General Hospital | Kuching | Sarawak | 93586 | Malaysia |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
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The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs.The patients recruited were randomized to receive one of the study packs. The study pack were numbered by the pharmacist, who used a computer-generated random number sequence to assign treatment allocations. The allocation list was kept by the pharmacist. Treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database.
| Metoclopramide |
| Drug |
One dose of intravenous metoclopramide 10mg |
|
| Placebo | Drug | Sodium chloride 0.9% |
|
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |