Pain Perception Clinical Trial
— COMFORTEMGOfficial title:
The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electromyography in Pediatric Population-A Randomized Controlled Trial
Verified date | February 2023 |
Source | Aga Khan University Hospital, Pakistan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | June 27, 2022 |
Est. primary completion date | June 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga khan University Hospital | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University Hospital, Pakistan |
Pakistan,
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Kalantar SS, Abbasi M, Faghihi-Kashani S, Majedi H, Ahmadi M, Agah E, Tafakhori A. Paracetamol 325 mg/tramadol 37.5 mg effect on pain during needle electromyography: a double-blind crossover clinical trial. Acta Neurol Belg. 2016 Dec;116(4):599-604. doi: 10.1007/s13760-016-0621-6. Epub 2016 Mar 8. — View Citation
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London ZN, Burke JF, Hazan R, Hastings MM, Callaghan BC. Electromyography-related pain: muscle selection is the key modifiable study characteristic. Muscle Nerve. 2014 Apr;49(4):570-4. doi: 10.1002/mus.23974. Epub 2014 Jan 25. — View Citation
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Taddio A, Hogan ME, Moyer P, Girgis A, Gerges S, Wang L, Ipp M. Evaluation of the reliability, validity and practicality of 3 measures of acute pain in infants undergoing immunization injections. Vaccine. 2011 Feb 4;29(7):1390-4. doi: 10.1016/j.vaccine.2010.12.051. Epub 2010 Dec 30. — View Citation
Taddio A, Ilersich AL, Ipp M, Kikuta A, Shah V; HELPinKIDS Team. Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: systematic review of randomized controlled trials and quasi-randomized controlled trials. Clin Ther. 2009;31 Suppl 2:S48-76. doi: 10.1016/j.clinthera.2009.07.024. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain perception of patient during NCS and EMG tests | 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. | Pain scores to be recorded immediately after the procedure | |
Secondary | Pain perception of patient according to guardian during NCS and EMG tests | Pain perception of patient according to guardian during NCS and EMG tests as measured by guardian-reported FPS-R | Pain scores to be recorded immediately after the procedure | |
Secondary | Effect of Patient demographics, Clinical characteristics and NCS / EMG procedure characteristics on patient pain scores | Effect of Patient demographics, Clinical characteristics and NCS / EMG procedure characteristics on patient pain scores within and across each of the intervention arms | Pain scores to be recorded immediately after the procedure |
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