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The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electrodiagnostic Testing (COMFORTEMG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337814
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Fazal ur Rehman, Aga Khan University Hospital, Pakistan

Brief Summary:
Electromyography (EMG) is a useful test for diagnosis and monitoring of lower motor neuron disorders. It is mostly done in conjunction with a Nerve Conduction Study (NCS). Like other invasive medical procedures; electrodiagnostic tests have been known to cause iatrogenic pain for the patient, the intensity of which varies from person to person. Multiple modifiable as well as non-modifiable risk factors associated with EMG pain have been described in literature.Various approaches targeting different mechanisms of pain perception have been tested to make this procedure comfortable for the patients. These approaches range from simple distraction techniques to the use of topical and oral analgesics.Most of these studies have looked at adult population which has, supposedly, better pain tolerance as compared to children. Data on EMG associated pain in pediatric population is scant. This trial will assess the effect of combined oral and topical analgesics to reduce pain perception during NCS and EMG tests in the pediatric population.

Condition or disease Intervention/treatment Phase
Pain Perception Drug: EMLA Cream Drug: Ibuprofen Drug: Placebo syrup Drug: Placebo cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled randamized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electromyography in Pediatric Population-A Randomized Controlled Trial
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: COTA Arm
Patients getting combined (C) oral (O) and topical (T) analgesics (A)
Drug: EMLA Cream
Topical anaesthetic cream

Drug: Ibuprofen
Oral analgesic syrup (non-steroidal anti inflammatory drug)

Experimental: OA Arm
Patients getting oral (O) analgesics (A) and topical placebo
Drug: Ibuprofen
Oral analgesic syrup (non-steroidal anti inflammatory drug)

Drug: Placebo cream
Placebo cream similar to EMLA

Placebo Comparator: Placebo Arm
Patients getting oral placebo and topical placebo
Drug: Placebo syrup
Placebo syrup similar to Ibuprofen

Drug: Placebo cream
Placebo cream similar to EMLA




Primary Outcome Measures :
  1. Pain perception of patient during NCS and EMG tests [ Time Frame: Pain scores to be recorded immediately after the procedure ]
    Pain perception of patient during NCS and EMG tests as measured by Modified Behavioral Pain Scale or patient reported Faces Pain Scale - Revised in COTA, OA and Placebo arms.


Secondary Outcome Measures :
  1. Pain perception of patient according to guardian during NCS and EMG tests [ Time Frame: Pain scores to be recorded immediately after the procedure ]
    Pain perception of patient according to guardian during NCS and EMG tests as measured by guardian-reported FPS-R

  2. Effect of Patient demographics, Clinical characteristics and NCS / EMG procedure characteristics on patient pain scores [ Time Frame: Pain scores to be recorded immediately after the procedure ]
    Effect of Patient demographics, Clinical characteristics and NCS / EMG procedure characteristics on patient pain scores within and across each of the intervention arms



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Pediatric patients (6 months to 18 years) referred for NCS / EMG testing to the neurophysiology lab at AKUH

Exclusion Criteria:

  • Patients not able to report pain scores on the scales used
  • Patients using sedatives and prior analgesics within last 24 hours of study
  • Patients with history of upper gastrointestinal tract bleed, renal disease, severe hepatic disease, glucose-6-phosphate deficiency, congenital or idiopathic methemoglobinemia
  • Patients with known sensitivity / allergy to Ibuprofen or EMLA cream or their components
  • Patients on class I antiarrhythmic drugs
  • Patients with breach of skin on topical analgesic/placebo application sites
  • Breastfeeding or sugary drink within one hour of start of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337814


Contacts
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Contact: Sara Khan, MD, DABPN 009234930051 ext 4654 sara.khan@aku.edu
Contact: Dureshahwar Kanwar, MBBS, FCPS 009234930051 ext 4974 dureshahwar.kanwar@aku.edu

Locations
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Pakistan
Aga khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 7400
Contact: Sara khan, MD    92 3332372708 ext 92 2134864654    sara.khan@aku.edu   
Contact: Dureshahwar kanwar, FCPS    92 3013976402 ext 92 2134864947    Dureshahwar.kanwar@aku.edu   
Principal Investigator: FAZAL UR REHMAN, FCPS         
Sponsors and Collaborators
Aga Khan University Hospital, Pakistan
Investigators
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Principal Investigator: Fazal Rehman, MBBS, FCPS Aga Khan University
Publications:

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Responsible Party: Fazal ur Rehman, Principal Inestigator, Aga Khan University Hospital, Pakistan
ClinicalTrials.gov Identifier: NCT04337814    
Other Study ID Numbers: 2019-0631-4863
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fazal ur Rehman, Aga Khan University Hospital, Pakistan:
Electromyopharpy
Nerve conduction study
Electrodiagnostic testing
Edx study
EMG
NCS
Additional relevant MeSH terms:
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Ibuprofen
Lidocaine, Prilocaine Drug Combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Anesthetics, Combined