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Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metamizole and Ibuprofen | Experimental | all patients (n=42) will receive metamizol and ibuprofen in one session. In the other session half will receive metamizol and placebo (n=21) and the other half will receive ibuprofen and placebo. The order will be randomized (balanced). |
|
| Metamizole and Placebo | Active Comparator | This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 |
|
| Ibuprofen and Placebo | Active Comparator | This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metamizole and Ibuprofen | Drug | Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve for pain in the first 12 postoperative hours | The primary outcome is the area under the curve for pain in the first 12 postoperative hours, as assessed by the numeric rating scale | first 12 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve for pain in the first 18 postoperative hours | This secondary outcome is the area under the curve for pain in the first 18 postoperative hours, as assessed by the numeric rating scale (NRS) | first 18 postoperative hours |
| highest pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilhelm Ruppen, PD Dr. med | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, University of Basel Hospital | Basel | 4031 | Switzerland |
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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 |
|---|---|
| D004177 | Dipyrone |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| Metamizole and Placebo | Drug | Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours |
|
| Ibuprofen and Placebo | Drug | Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours |
|
This secondary outcome is the highest pain score registered during the observation period, as assessed by the numeric rating scale |
| total observation period (maximum 18 hours) |
| night time pain | This secondary outcome is the overall pain during the first night after the intervention, as assessed by the numeric rating scale | first night after the intervention |
| need for and timing of rescue medication | This secondary outcome is the marked "yes" or "no", depending on whether a rescue medication (extra pain medication) was needed or not | total observation period (maximum 18 hours) |
| haemorrhage requiring intervention | This secondary outcome is the marked "yes" or "no", depending on whether an intervention to stop haemorrhage was needed or not | total observation period (maximum 18 hours) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |