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

NCT04337814 | Completed

• 1 other identifier: 2019-0631-4863
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception

Keywords

Electromyopharpy; Nerve conduction study; Electrodiagnostic testing; Edx study; EMG; NCS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain perception of patient according to guardian during NCS and EMG tests

  Pain scores to be recorded immediately after the procedure

• Effect of Patient demographics, Clinical characteristics and NCS / EMG procedure characteristics on patient pain scores

  Pain scores to be recorded immediately after the procedure

Study Arms (3)

COTA Arm

EXPERIMENTAL

Patients getting combined (C) oral (O) and topical (T) analgesics (A)

Drug: EMLA Cream; Drug: Ibuprofen

OA Arm

EXPERIMENTAL

Patients getting oral (O) analgesics (A) and topical placebo

Drug: Ibuprofen; Drug: Placebo cream

Placebo Arm

PLACEBO COMPARATOR

Patients getting oral placebo and topical placebo

Drug: Placebo syrup; Drug: Placebo cream

Interventions

EMLA Cream DRUG

Topical anaesthetic cream

COTA Arm

Ibuprofen DRUG

Oral analgesic syrup (non-steroidal anti inflammatory drug)

COTA Arm; OA Arm

Placebo syrup DRUG

Placebo syrup similar to Ibuprofen

Placebo Arm

Placebo cream DRUG

Placebo cream similar to EMLA

OA Arm; Placebo Arm

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga khan University Hospital

Karachi, Sindh, 7400, Pakistan

Location

Related Publications (16)

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  PMID: 831658 BACKGROUND

• Strommen JA, Daube JR. Determinants of pain in needle electromyography. Clin Neurophysiol. 2001 Aug;112(8):1414-8. doi: 10.1016/s1388-2457(01)00552-1.

  PMID: 11459681 BACKGROUND

• 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.

  PMID: 23893537 BACKGROUND

• Yalinay Dikmen P, Ilgaz Aydinlar E, Karlikaya G. Expected and Experienced Pain Levels in Electromyography. Noro Psikiyatr Ars. 2013 Dec;50(4):364-367. doi: 10.4274/npa.y6699. Epub 2013 Dec 1.

  PMID: 28360571 BACKGROUND

• Pohl M, Rosler A, Sunkeler I, Braune HJ, Oertel WH, Lautenbacher S. Insertion pain in needle electromyography can be reduced by simultaneous finger slapping. Neurology. 2000 Mar 14;54(5):1201-2. doi: 10.1212/wnl.54.5.1201-a. No abstract available.

  PMID: 10720303 BACKGROUND

• Annaswamy TM, Morchower AH. Effect of lidocaine iontophoresis on pain during needle electromyography. Am J Phys Med Rehabil. 2011 Dec;90(12):961-8. doi: 10.1097/PHM.0b013e318228c6d3.

  PMID: 22019960 BACKGROUND

• Lamarche Y, Lebel M, Martin R. EMLA partially relieves the pain of EMG needling. Can J Anaesth. 1992 Oct;39(8):805-8. doi: 10.1007/BF03008292.

  PMID: 1288906 BACKGROUND

• 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.

  PMID: 26957290 BACKGROUND

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  PMID: 18663736 BACKGROUND

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  PMID: 26852012 BACKGROUND

• 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.

  PMID: 19781436 BACKGROUND

• Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline. CMAJ. 2010 Dec 14;182(18):E843-55. doi: 10.1503/cmaj.101720. Epub 2010 Nov 22. No abstract available.

  PMID: 21098062 BACKGROUND

• 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.

  PMID: 21195076 BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• von Baeyer CL. Children's self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag. 2006 Autumn;11(3):157-62. doi: 10.1155/2006/197616.

  PMID: 16960632 BACKGROUND

• Abuelkheir M, Alsourani D, Al-Eyadhy A, Temsah MH, Meo SA, Alzamil F. EMLA(R) cream: a pain-relieving strategy for childhood vaccination. J Int Med Res. 2014 Apr;42(2):329-36. doi: 10.1177/0300060513509473. Epub 2014 Feb 5.

  PMID: 24501164 BACKGROUND

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Ibuprofen

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Fazal Rehman, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Haris Hakeem, MBBS, FCPS, FRACP

  Aga Khan University Hospital, Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inestigator

Model Details: Double blind placebo controlled randamized controlled trial

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: April 8, 2020
• Study Start: December 30, 2019
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)