Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture and Myelogram
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 and myelogram.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Non Hodgkin Lymphoma |
Drug: nitrous oxide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture and Myelogram |
- Compare analgesic efficacy of EMLA versus Nitrous oxide [ Time Frame: Within first hour after the procedures ] [ Designated as safety issue: Yes ]
- Evaluate analgesic synergism of EMLA versus nitrous oxide [ Time Frame: One hour after the procedures ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
-
Drug: nitrous oxide
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 14 years old submitted to lumbar puncture and myelogram. The evaluation will be done based on a valid pain scale (face scale or visual numeric scale - VNS) during well-known painful procedures (lumbar puncture and myelogram) that will take place in the Hematologic Pediatric Ambulatory from Hospital das Clinicas at the University of Minas Gerais (UFMG). All the studied procedures will have clinical indication and will not be held by the researcher. One of the researches will be responsible for the drugs and/or placebo administration and another researcher will be responsible for pain and stress evaluation during the procedures. The children will be aleatorily divided within three groups A, B and C as follow: Group A (n=40)EMLA + Oxygen (lumbar puncture; n=20 and myelograms; n=20); Group B (n=40)EMLA + Livopan®, (lumbar puncture; n=20 and myelograms; n=20); Group C (n=40) Livopan® + placebo cream, (lumbar puncture; n=20 and myelogram; n=20.
All children will undergo a therapeutic proposal, moreover the purpose of this study is to valid not only control measures application but also pain treatment while performing these well-known painful procedures. According to the clinical practice, although those procedures are necessary and frequent, unfortunately, a few or none medical intervention is performed.
Eligibility| Ages Eligible for Study: | 4 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age between four and 14 years;
- Not present cognitive disabilities;
- Necessity to perform the clinical procedure;
- Accordance in participating in the study.
Exclusion Criteria:
- Continuity skin lesion in the procedure site;
- Metahemoglobinemia;
- Neuromuscular disability;
- Presence of pneumothorax, emphysema, intra-abdominal infection, cranioencephalic traumatism, otitis media, sinusitis and intracranial hypertension;
- Vitamin B12 known deficits;
- Urgency for the procedure;
- Disagreement in participating of the project;
- Patients in use of Dapsone.
Contacts and Locations| Contact: Yerkes Pereira Silva, PhD | 0055 31 9993 3384 | yerkesps@uol.com.br |
| Contact: Claudirene Milagres Araujo, RN | 0055 31 9903 2405 | claudirene_milagres@hotmail.com |
| Brazil | |
| Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais | Not yet recruiting |
| Belo Horizonte, Minas Gerais, Brazil | |
| Contact: Claudirene M Araujo, RN 0055 31 99032405 claudirene_milagres@hotmail.com | |
| Principal Investigator: Claudirene M Araujo, RN | |
| Principal Investigator: | Yerkes Pereira Silva, PhD | Federal University of Minas Gerais |
More Information
No publications provided
| Responsible Party: | Yerkes Pereira e Silva, Federal University of MInas Gerais |
| ClinicalTrials.gov Identifier: | NCT00808171 History of Changes |
| Other Study ID Numbers: | CAAE0450020300008 |
| Study First Received: | December 12, 2008 |
| Last Updated: | December 15, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of Minas Gerais:
|
lumbar punction myelogram pain assessment nitrous oxide and EMLA Leukemia and non Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nitrous Oxide Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013