Health TrialsbyHealthPanel

Effectiveness of 10% Lidocaine on Relieving Pain Caused by Intravenous Intubation

ConditionPregnancy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPhenikaa University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Inclusion criteria comprised participants who were going to undergo a scheduled C-section delivery

Over 18 years old

Able to read and write Vietnamese.

Sign the consent form

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocain spray

    Drug

    Applying 3 spray of 10% Lidocaine to the IV insertion site in women before their C-section

  • Sterilized saline solution

    Combination product

    Participants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group 2Placebo comparator 1 intervention
Group B: Group 3No intervention 0 interventions
Group C: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain score

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.

Time frame
After the nurse insert the IV into the participants

Secondary outcomes

1

Adverse event

Side effects cause by Lidocaine

Time frame
List any side effect of Lidocaine reported by participant or observed by PI within 2 hours after the IV has been inserted

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phenikaa University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: