Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A prospective, randomized, double-blind, controlled trial on the application of a 10%-lidocain spray prior to the insertion of a peripheral intra-venous catheter in female adults

This research is a study about making a common medical procedure less painful. It focuses on adult women who need an IV drip, which is a small tube placed into a vein, usually in the arm or hand. The study will test if using a numbing spray on the skin before inserting the IV can help reduce the pain. Researchers will compare this numbing spray to a dummy spray (which contains no medicine) to see if it truly makes a difference. The main goal is to measure how much pain people feel during the IV insertion and see if the numbing spray helps. This type of study is often done after a medicine is already approved for other uses, to find new ways to improve patient comfort.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Ordensklinikum Linz GmbH

Enrolment target

Start

18 Mar 2024

Pain

What is this study about?

When you go into hospital or need certain medical treatments, you might need an IV drip. This is when a small, flexible tube is gently placed into one of your veins, often in your hand or arm. It's a very common procedure, but for many people, the initial needle prick can be a bit uncomfortable or even painful. This study is designed to look into a simple way to make this process easier.

The researchers want to see if a special numbing spray, containing a medicine called lidocaine, can reduce the pain felt when an IV drip is put in. They will be comparing this active numbing spray to a 'dummy' spray that looks and feels the same but doesn't contain any medicine. This helps them to know for sure if any pain relief experienced is due to the numbing spray itself, and not just the idea of having a spray used.

Participants will be asked to rate their pain level after the IV is inserted. The study will also look at whether where the IV is placed (like the hand or forearm) makes a difference to the pain, how successful the IV insertion is, and how people's expected pain compares to the actual pain they feel. The main goal is to find practical ways to improve comfort for patients during a routine, but sometimes dreaded, medical procedure.

Key takeaways

This study tests a numbing spray for IV pain.
It's for adult women needing an IV drip.
Compares numbing spray to a dummy spray.
Aims to make IV insertion less painful.
Participation involves a short pain rating.

Who may be eligible?

This study is specifically looking for volunteers who are adult women, aged 18 years or older. There is no upper age limit, so women of any adult age can potentially take part.

To be considered for this study, you would need to be a woman who is about to have an IV drip inserted for medical reasons. The study is focused on this particular procedure.

If you're an adult woman needing an IV, this study might be an option for you to consider.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman?
Are you 18 years old or older?
Are you going to have an IV drip inserted?
Are you able to understand and follow simple instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve a few simple steps related to your IV insertion. Before the IV is placed, a spray would be applied to the area of your skin where the IV will go. You would either receive the numbing spray with lidocaine or a dummy spray, but neither you nor the staff would know which one you're getting. After the IV is successfully put in, you would be asked to rate how much pain you felt using a simple scale. There are no extra visits or long follow-up appointments required beyond the time of your IV insertion. The total duration of your participation would only be for the short period around when your IV is being inserted.

Potential risks and benefits

Taking part in this study might offer the potential benefit of reduced pain during your IV insertion if you receive the active numbing spray. However, you might also receive the dummy spray and not experience any direct benefit from the spray itself. The risks associated with the numbing spray are generally very low, as it's a commonly used medication for numbing the skin. These could include mild irritation where the spray is applied. The risks from the IV insertion itself are the same as if you weren't in the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is an IV drip?

An IV drip is a small tube put into your vein, usually in your arm or hand, to give you fluids or medicine directly into your bloodstream.

What is a 'numbing spray'?

It's a spray used on the skin to make it less sensitive, so you feel less pain when something like an IV needle goes in.

Will I know if I get the real numbing spray or a dummy spray?

No, neither you nor the healthcare team will know, so that the results of the study are fair and accurate.

Why are only women included in this study?

Sometimes studies focus on specific groups to better understand how a treatment works for them. In this case, they are focusing on adult women.

What do I have to do if I join?

You'll have a spray applied to your skin before your IV, and then you'll be asked to rate your pain for a short moment after the IV is inserted.