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There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.
The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Active Comparator | Group L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure |
|
| Group P | Placebo Comparator | Normal saline solution administered under the same regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The prevention of the composite "nausea / or vomiting" | 24 hours | |
| Compare frequency of vomiting by baseline risk | 24 hours | |
| Time to first vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando R Altermatt, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| División de Anestesia - Facultad de Medicina Pontificia Universidad Católica | Santiago | Santiago Metropolitan | 8330024 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29570108 | Derived | Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010146 | Pain |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline |
| Drug |
Sodium Chloride 0.9% infusion |
|
|
| 24 hours |
| Time at which discharge criteria are met Postanesthesia care unit (PACU) | 24 hours |
| Length of stay in PACU unit | 24 hours |
| PACU opioid consumption | 24 hours |
| Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate | 24 hours |
| Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale | 24 hours |
| Time to first emetic drug administered | 24 hours |
| Type and number of doses of antiemetic drug required during hospitalization | 24 hours |
| Total length of stay | 24 hours |
| Analysis of cost-effectiveness. | 24 hours |
| D012816 | Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |