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

NCT04337814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2023-02-28

No results posted yet for this study

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.

Conditions

  • Pain Perception

Interventions

DRUG

EMLA Cream

Topical anaesthetic cream

DRUG

Ibuprofen

Oral analgesic syrup (non-steroidal anti inflammatory drug)

DRUG

Placebo syrup

Placebo syrup similar to Ibuprofen

DRUG

Placebo cream

Placebo cream similar to EMLA

Sponsors & Collaborators

  • Aga Khan University Hospital, Pakistan

    lead OTHER

Principal Investigators

  • Fazal Rehman, MBBS, FCPS · Aga Khan University

  • Haris Hakeem, MBBS, FCPS, FRACP · Aga Khan University Hospital, Monash University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2022-06-27
Completion
2022-06-27

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04337814 on ClinicalTrials.gov