Clinical trial · Interventional
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
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
NCT00808171CI-TRIAL-00015236completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMLA | Drug | — | UNRESOLVED |
| Livopan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EMLA and Livopan
- description
- Administered EMLA and Livopan
- interventionNames
- Drug: Livopan
- Drug: EMLA
- type
- EXPERIMENTAL
- label
- EMLA and gas placebo
- description
- Administered EMLA and oxygen
- interventionNames
- Drug: EMLA
- type
- EXPERIMENTAL
- label
- Livopan and placebo cream
- description
- Administered Livopan and placebo cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSteedman 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. PMID 16999723