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| Name | Class |
|---|---|
| Santa Casa de Misericórdia de Belo Horizonte | OTHER |
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Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both |
|
| C | Active Comparator | compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine |
|
| M | Active Comparator | compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine |
|
| CM | Active Comparator | compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 1 mcg/kg |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| The overall postoperative consumption of analgesics. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The peroperative consumption of volatile anesthetics. | 3 hours | |
| The peroperative Bispectral Index measure. | 3 hours | |
| Postoperative Wong-Baker faces scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renato S Gomez, PhD, MD | Federal University of Minas Gerais | Study Director |
| Magda L Fernandes, M | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Belo Horizonte Hospital | Belo Horizonte | Minas Gerais | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16094063 | Background | Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9. | |
| 10084100 | Background | Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x. |
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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 |
|---|---|
| D003000 | Clonidine |
| D009020 | Morphine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
20 mcg/kg |
|
| Bupivacaine plus clonidine and morphine | Drug | bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg |
|
| Bupivacaine | Drug | Caudal anesthesia with bupivacaine 0,166% 1 ml/kg |
|
| 24 hours |
| Postoperative pain and discomfort score scale | 24 hours |
| 17513626 | Background | Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |