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Study to assess the analgesic efficacy in the prevention of postoperative pain in children undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of Metamizol in this group of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium metamizol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium metamizol | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of children requiring rescue medication | up to 4 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication | up to 4 hours | |
| Percentage of children who require rescue medication | up to 2 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C024864 | metamizole magnesium |
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| Drug |
|
| Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS) | up to 4 hours |
| Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS) | up to 4 hours |
| Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test | up to 4 hours |
| Assessment of the partial efficacy by the investigator by means of a four points VRS | up to 4 hours |
| Assessment of the total efficacy by the investigator by means of a four points VRS | after 4 hours |
| Number of patients with adverse events (AE) | up to 4 hours |
| Number of withdrawals due to AEs | up to 4 hours |
| Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS | after 4 hours |