Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Prilocaine

Lidocaine, Prilocaine Drug Combination

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray.

EMLA

Placebo

Chen Wee Aw, MBBS

Chee Wei Teoh, MBBS

Aims:

The investigators main purpose is to assess the efficacy of analgesia provide by topical lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid nitrogen cryotherapy in adults.

Methodology:

The study is a single-centre, double-blind, randomized, placebo-controlled, parallel-group trial with one visit. The investigators planned to include at least 64 patients in 4 months. Adult patients (at least 21 years old) diagnosed with plantar warts are potential subjects for the study.

Once a potential subject is identified, the field investigator will assess him/her for eligibility to enter the study. Then, the potential subject will be provided with full and adequate verbal and written information about the nature, purpose, possible risks and benefits of the study. If the subject agrees to enroll into the study, a signed informed consent will be obtained from him/her.

All patients are randomly assigned by computer-generated randomization sequence to receive either eutectic lidocaine/prilocaine cream (EMLA)® 5% or placebo 60 mins prior to application of cryotherapy. The plantar warts are pared with shape blade before applying EMLA®or placebo cream. Based on the randomization, an designated dermatology laboratory technician will apply either the EMLA® cream 5% or placebo cream to the wart lesions. The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray. The lesions are treated with double freeze-thaw cycle. The end point of each freeze is a complete ice-ball covering the lesion with 1-2mm peripheral extension. The study involved only one treatment with either placebo or EMLA® cream 5% followed by cryotherapy as described. No other analgesic other than the EMLA® cream 5% or placebo is allowed at least 2 hours prior to or during cryotherapy.

A 100 mm visual analogue pain scale (VAS) is used to denote pain severity ranging from "no pain" (0 mm) to the "worst possible pain" (100 mm). The patient will choose a distance from the "no pain" anchor closest to the pain experienced during cryotherapy for wart removal. Pain is evaluated in each participant using a self-administered VAS immediately after cryotherapy treatment.

Potential Benefits:

The potential benefits are:

1. The patients may experience less pain during application cryotherapy.
2. The application of local anesthetic cream may possibly increase the effectiveness of cryotherapy.

Potential Risks:

EMLA cream® is known to be relatively safe with minimal side effects. The commonest side effect would be local irritation to the skin e.g. redness, itchiness which is reversible after removal of the cream. Very rarely (\<1000), severe allergic reaction can occur with application of EMLA cream® (AstraZeneca information brochure).

Efficacy Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris

A Double-Blind, Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris in Adults

At the end of the treatment i.e.Pain VAS will be assessed 60 mins after application of the study cream

National University Hospital, Singapore

Aw Chen Wee

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Pain

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Analgesics

Vasodilator Agents

Respiratory System Agents

Nitrous Oxide

Nitric Oxide

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

Inhalation of oxygen and nitrous oxide 50%

Livopan

Yerkes P Silva, PhD

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.

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

Federal University of Minas Gerais

Nervous System Diseases

Skin Neoplasms

Head and Neck Neoplasms

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Ethyl Chloride

EMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study

Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study

Ethyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate.

Ethyl chloride

Aqueous cream BP

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

Operations on cutaneous tissues of the head and neck are some of the most frequently performed types of operation performed. They can often successfully be performed using local anaesthetic (LA). However, tissues in this anatomic area are some of most sensitive tissues in the body to nociceptive pain. As such, local anaesthetic can be a distressing experience for patients in many ways. Unfortunately, it is also the most common anatomical site for cutaneous malignancies. The majority of these lesions are resected under local anaesthetic. However, one of the major disadvantages of local anaesthetic such as lidocaine is pain during administration.

Several interventions have been used to reduce pain from needles and injections including ethylene chloride cryoanalgesic spray and topical anaesthetic agents including EMLA (lidocaine and prilocaine) and Ametop ointments. These have been extensively used in paediatric populations with great success to reduce pain during procedures requiring hypodermics such as cannulation. Several studies have trialled these interventions in adult populations across a variety of anatomical locations with variable results. The investigators aim to assess the efficacy of EMLA and ethyl chloride in mitigating nociceptive pain associated with local anaesthetic administration in patients undergoing cutaneous head and neck surgery.

Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.

Topical Anaesthesia in Cutaneous Head and Neck Surgery

Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial

The primary outcome measure is patient reported pain on a numeric rating scale (NRS)(1; no pain, 10; worst pain imaginable) recorded after LA administration

Patient satisfaction measured on NRS scale of 1=not bad at all, to 10=worst experience imaginable recorded immediately postoperatively

University Hospital Waterford

Principal Investigator

Adjuvants, Anesthesia

Anticoagulants

Other Dietary Supplements

Fentanyl

Propofol

Citric Acid

Sodium Citrate

Hypnotics and Sedatives

Anesthetics, Intravenous

Analgesics, Opioid

Narcotics

Citrate

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

placebo administration

propofol

fentanyl citrate

Dudley Hammon

This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary

PRIMARY OBJECTIVES:

I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.

SECONDARY OBJECTIVES:

I. To determine whether the use of EMLA cream decreases complication rates from sedation.

II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.

III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

ARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

After completion of study treatment, patients are followed up within 1 week.

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications.

Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter.

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

The principal investigator reports there were no adverse events during the randomized trials.

TRIALS COMPLETED is the unit of measure, not participants.

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation

Arm A (EMLA)

TRIALS COMPLETED is the unit of measure, not participants.

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation

Arm B (Placebo)

Trials completed is the unit of measure, not participants.

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation

Trials completed is the unit of measure, not participants.

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation

Total

Age, Continuous

Sex: Female, Male

Participants were not randomized, the trials were randomized so we are using the trials (completed) to report demographics by arm

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants were not randomized to the arms. The trials for each arm were randomized so we are using the trials to report demographics by arm.

Thomas McLean

Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation

Participants were not randomized. Trials were randomized so we will have to use the trials to report by arm

Total Dose of Propofol Administered to Each Patient

No movement

Minor movement

Major movement

Other

Participants were not randomized. Trials were randomized so we will use the trials to report by arm

Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration

Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.

Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream

Atraumatic

Traumatic

Bloody

Total number of trials was 136, 15 are missing. Participants were not randomized. Trials were randomized so will use the trials to report by arm.

Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration

Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream

Overall Study

The patient will receive 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. The site of EMLA application will be covered with Tegaderm dressing.

The patient will receive sham-EMLA cream (a fragrance-free hypoallergenic moisturizer cream) will be applied at least 60 minutes per standard protocol with Tegaderm dressing.- Following conscious sedation, the patient will receive lidocaine 1% injection (\~1-2ml) at the appropriate site 30-60 seconds prior to LP needle insertion.

EMLA cream (lidocaine 2.5% and prilocaine 2.5%)

Mohamad Badawi, MD

A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in which a needle is inserted into the spinal canal. In this population, LPs are most commonly performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal cord) for diagnostic testing, and to inject medications including chemotherapy. Local analgesic (pain control medicine) during pediatric LP procedures is underutilized and not standardized. The first local analgesic routinely used for LP procedures was lidocaine injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved by the FDA for local skin use in pediatric patients, has provided an additional option for local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain control in the pediatric population has not been performed. Pediatric oncology patients often require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of standardization of LP analgesia in this population, the investigators have designed a prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine injection in reducing pain associated with LP in children being treated for leukemia or lymphoma.

Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures

Pain was self-reported by the child using the validated pain scale, Wong-Baker Faces Pain Rating Scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain, with higher the number, greater the pain.

Below are the median and range of values (minimal to maximal) reported by each arm's 10 patients. Reported values were identical between arms.

Use of PRN or "as needed" pain medicine by the patient was determined. Patients with parent/guardian assistance were asked to record the "as needed" pain control medication, acetaminophen. the patient used within the 24 hours after lumber puncture. Counts of patients using acetaminophen in the 24 hours following lumber puncture are reported.

CAMC Health System

Assistant Professor WVU-Charleston

Participants who received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure, either the first or second lumbar puncture included in the study.

Participants who received sham-EMLA cream (applied at least 60 minutes prior to procedure) and following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) at the appropriate site 30-60 seconds prior to prior to procedure, either the first or second lumbar puncture included in the study.

Lidocaine Injection

First lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure.

Subsequent lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion.

EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture

First lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure.

Subsequent lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris	NCT01330615	Plantar Warts	EMLA Placebo	21 Years -	National University Hospital, Singapore
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture	NCT00808171	Leukemia Non Hodgkin Lym...	Livopan Livopan EMLA	4 Years - 14 Years	Federal University of Minas Gerais
Topical Anaesthesia in Cutaneous Head and Neck Surgery	NCT06274905	Pain, Acute Head and Neck C... Cutaneous Tumor	EMLA Ethyl chloride Aqueous cream B...	18 Years -	University Hospital Waterford
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture	NCT00808171	Leukemia Non Hodgkin Lym...	Livopan Livopan EMLA	4 Years - 14 Years	Federal University of Minas Gerais
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures	NCT01516684	Malignant Neopl...	placebo adminis... EMLA propofol fentanyl citrat...	- 22 Years	Wake Forest University Health Sciences
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures	NCT04003012	Leukemia-Lympho...	EMLA Lidocaine	3 Years - 18 Years	CAMC Health System

Spots Global Cancer Trial Database for emla

Every month we try and update this database with for emla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for emla

Every month we try and update this database with for emla cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for emla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.