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In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.
It is a randomized controlled clinical trial, double blinded, with the purpose to compare the use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50% in oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years old submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the Wong Baker faces scale and the visual numeric scale during six observational periods: baseline; three minutes after gas administration and before the first attempt of lumbar puncture; during the first lumbar puncture attempt; during the chemotherapy administration; during needle remove and three minutes after gas interruption. All the studied procedures will have clinical indication and will not be held by the researcher. The children was random divided within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group B (n=19)EMLA + gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.
Primary outcome was the detection of a difference of 20% or more in the visual numeric scale between the three treatment groups during the first attempt of lumbar puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA and Livopan | Experimental | Administered EMLA and Livopan |
|
| EMLA and gas placebo | Experimental | Administered EMLA and oxygen |
|
| Livopan and placebo cream | Experimental | Administered Livopan and placebo cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livopan | Drug | Inhalation of oxygen and nitrous oxide 50% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare analgesic efficacy of EMLA versus Nitrous oxide | Within first hour after the procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate analgesic synergism of EMLA versus nitrous oxide | One hour after the procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yerkes P Silva, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais | Belo Horizonte | Minas Gerais | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16999723 | Background | Steedman B, Watson J, Ali S, Shields ML, Patmore RD, Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow examination. Clin Lab Haematol. 2006 Oct;28(5):321-4. doi: 10.1111/j.1365-2257.2006.00807.x. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D000813 |
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| Livopan | Drug | equimolar mixture of N2O/O2 |
|
|
| EMLA | Drug | Lidocaine-prilocain cream |
|
|
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |