Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-28 @ 5:24 PM
Study NCT ID:
NCT07212192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of 10% Lidocaine on Relieving Pain Caused by Intravenous Intubation
Sponsor:
Phenikaa University
Organization:
Study Overview
Official Title:
Effectiveness of 10% Lidocaine Spray on Relieving Local Pain Caused by Intravenous (IV) Intubation: a Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: