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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808171

Enrollment

Registered

2008-12-15

Start date

2009-02-28

Completion date

2011-08-31

Last updated

2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Non Hodgkin Lymphoma

Keywords

lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGLivopan

Inhalation of oxygen and nitrous oxide 50%

DRUGEMLA

Lidocaine-prilocain cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 14 Years

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.

Design outcomes

Primary

Measure	Time frame
Compare analgesic efficacy of EMLA versus Nitrous oxide	Within first hour after the procedures

Secondary

Measure	Time frame
Evaluate analgesic synergism of EMLA versus nitrous oxide	One hour after the procedures

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026