Effectiveness of 10% Lidocaine Spray on Relieving Local Pain Caused by Intravenous (IV) Intubation: a Randomized Control Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
The goal of this clinical trial is to learn if 10% Lidocaine spray can reduce local pain caused by intravenous (IV) intubation among women. The main questions it aims to answer are:
- Does 10% Lidocaine spray lower the VAS score in participants need intravenous intubation?
- What size effect of 10% Lidocaine spray when patients administered? Researchers will compare 10% Lidocaine spray to a placebo (a look-alike substance that contains no drug) to see if 10% Lidocaine spray works to reduce local pain caused by intravenous (IV) intubation
Participants will:
- Receive 3 spray of 10% Lidocaine at intravenous catheter insertion site before the nurse perform the IV insert procedure
- Assess the pain cause by IV insertion using VAS
Detailed Description
Intravenous (IV) cannulation is a technique in which a cannula is placed inside a vein through the patient's skin. It is the most commonly performed procedure in clinical settings. Nevertheless, it is also the second most painful procedure that significantly elevates a patient's anxiety levels. IV is required for every patient before their operation. Managing this pre-operative pain has been listed as an indicator of the quality of anesthesia. As such, various interventions have been conducted to reduce the pain caused by intravenous intubation among patients. Non-pharmacological approaches to reduce this pain include using the flash of light to distract patients, cough tricks, Valsalva manoeuvers, and vapor coolant spray, essential oil . Pharmacological approaches for reducing local pain caused by IV include Lidocaine cream/patch/spray, EMLA (mixture of Lidocaine and Prilocain), diclofenac transdermal, and Piroxicam gel . However, none of these methods exhibited a clear superiority over the others. There is no clear consensus about which method is the best option to relieve pain induced by IV. Among pharmacological approaches, using Lidocaine provides some promising results in reducing pain related to IV insertion. Among the different dosage forms, Lidocaine spray is the most convenient with a fast effect. It is quickly absorption within 1 to 5 minutes. However, inconsistent results have been reported regarding this application . Notably, previous trials conducted in different populations, ages, settings, and needle sizes somewhat cause bias in the results. As such, more trials with rigorous design should be implemented to provide strong evidence to support the role of Lidocaine spray in reducing local paint caused by IV intubation. The objective of this study was to evaluate the effect of Lidocaine spray on relieving local pain caused by intravenous intubation. To ensure a homogeneous population, we chose the participants who were women before their Cesarean section delivery (C-section).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 2
Participants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein
Intervention: Sterilized saline solution (Combination Product)
Intervention
Participants will be given three sprays of 10% Lidocaine (Lidocaine 10% pump spray, Egis) 3 minutes before the interventionist performed the insertion of a catheter into their vein
Intervention: Lidocain spray (Drug)
Outcomes
Primary Outcomes
Pain score
Time Frame: After the nurse insert the IV into the participants
The Pain score will be measured by a visual analog scale (VAS). This is a validated, subjective measure of pain. It is typically a 10-cm line, used to assess a person's perception of pain, discomfort, or other subjective feelings by having them mark a point on the line that best represents their experience. It ranged from 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain ever". The greater score, indicate greater pain.
Secondary Outcomes
- Adverse event(List any side effect of Lidocaine reported by participant or observed by PI within 2 hours after the IV has been inserted)
Investigators
Hoang T.X Huong
Vice - Dean of Nursing Faculty
Phenikaa University