The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electromyography in Pediatric Population-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Pain perception of patient during NCS and EMG tests
研究概览
简要总结
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.
详细描述
Objectives:
To determine the effect of combined oral and topical analgesics (COTA) in reducing pain perception during NCS and EMG tests among the pediatric population.
To compare the effect of COTA and only oral analgesics (OA) in reducing pain perception during NCS and EMG tests among the pediatric population.
Methods:
Study Setting: This study will be conducted at the neurophysiology lab at Aga Khan University Hospital (AKUH)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (6 months to 18 years) referred for NCS / EMG testing to the neurophysiology lab at AKUH
排除标准
- •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
研究组 & 干预措施
COTA Arm
Patients getting combined (C) oral (O) and topical (T) analgesics (A)
干预措施: EMLA Cream (Drug)
COTA Arm
Patients getting combined (C) oral (O) and topical (T) analgesics (A)
干预措施: Ibuprofen (Drug)
OA Arm
Patients getting oral (O) analgesics (A) and topical placebo
干预措施: Ibuprofen (Drug)
OA Arm
Patients getting oral (O) analgesics (A) and topical placebo
干预措施: Placebo cream (Drug)
Placebo Arm
Patients getting oral placebo and topical placebo
干预措施: Placebo syrup (Drug)
Placebo Arm
Patients getting oral placebo and topical placebo
干预措施: Placebo cream (Drug)
结局指标
主要结局
Pain perception of patient during NCS and EMG tests
时间窗: 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.
次要结局
- 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)
研究者
Fazal ur Rehman
Principal Inestigator
Aga Khan University Hospital, Pakistan