Efficacy of eutectic mixture of local anaesthetic cream to reduce intravenous cannulation pain in children - A randomized control study
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Reduction in intravenous cannulation pain using eutectic mixture of local anaesthetic cream using visual analog scale pain score and FLACC scale and 4 point pain scale
研究概览
简要总结
This randomized controlled double blinded study will be conducted in the Department of Paediatrics, Sri Manakula Vinayagar Medical College And Hospital (SMVMCH) a tertiary care hospital in Puducherry after the approval of Research Committee and Institutional Ethics Committee. Any child from 3-12 years of age satisfying selection criteria will be recruited in the study after obtaining written informed consent from parents of all participants and oral assent for children above 7 years.
Sequentially numbered Sealed Opaque envelopes will be opened by Post Graduate or Intern and the child will be allotted to the respective intervention group as per the block randomized list. Baseline sociodemographic details including anthropometry, indication of cannulation, site and size of cannula will be recorded in proforma.
After explaining the procedure, non-dominant hand(unless otherwise specified) will be chosen and a suitable vein on the dorsum of the hand will be selected. Consequently 1.5 gram of placebo(CETAPHIL MOISTURIZER LOTION ) with same color as EMLA cream for Group A and 1.5gram of EMLA cream ( PRILOX CREAM )for Group B and Group C will be taken in gauze and applied in 3x3 cm size with an occlusive dressing by same Post Graduate or Intern blinding the child parents to the group .
The occlusive dressing will be removed after 30 minutes in Group A and Group B and after 60 minutes for Group C. The area will be wiped dry with gauze and observed for signs of any local reactions. After disinfecting the site with spirit, intravenous cannulation will be performed with 24 gauge or 22 gauge IV cannula by staff nurse.
A Principal Investigator blinded to interventions will ask the participants between age groups 7 to 12 years to rate the pain they felt during cannulation on a standard 100mm visual analogue scale from 0 = no pain to 100 = worst possible pain. Children aged 3 to 7 years will be observed and scored for pain behaviors by Principal Investigator during intravenous cannulation by using the Face, Leg, Activity, Cry and Consolability (FLACC) behavioral Pain scale coded as mild(0-3),moderate(4-6) and severe(7-10). The assessor also rates the pain using 4 point scale with 0 being no response, 1 mild facial grimace, 2 verbal response and 3 withdrawal of hand. Since assessment of pain is our primary objective we have used multiple scales that are age appropriate, both subjective and objective scales to minimize bias.
Heart rate and blood pressure will be recorded before and immediately after cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children between age groups 3 years to 12 years requiring non-emergent Intravenous cannulation 2.Parents who are willing to participate in the study and giving informed written consent.
排除标准
- •1.Emergency situations requiring immediate intravenous access 2.History of atopy 3.Open wounds or rash on dorsum of hand 4.Hypersensitivity to Eutectic mixture of local anaesthetic cream 5.Facial anomalies( preventing typical facial expressions of pain ) 6.Cognitive dysfunction and conditions affecting ability to rate pain 7.Local erythema or blanching following eutectic mixture of local anaesthetic cream application 8.Requiring more than one attempt for cannulation 9.Children with poorly visible veins 10.Parents not willing to participate and give consent for study.
结局指标
主要结局
Reduction in intravenous cannulation pain using eutectic mixture of local anaesthetic cream using visual analog scale pain score and FLACC scale and 4 point pain scale
时间窗: Outcome (reduction in intravenous cannulation pain assessed using pain scales) will be assessed at specific time based on group which participants randomized. For Group A - assessed after 30 minutes application of placebo | Group B - assessed after 30 minutes application of EMLA | Group C - assessed after 60 minutes application of EMLA
次要结局
- To study the timing of application of topical EMLA cream for intravenous cannulation in children(30 minutes and 60 minutes application time)
研究者
THAMIZSELVAN G
Sri manakula vinayagar medical College and hospital