Ice Therapy for Injection Site Pain

No longer recruiting at 1 trial location

Overseen By Jade Moon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Anti-VEGF

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using ice before eye injections reduces pain compared to not using ice. It focuses on individuals receiving anti-VEGF injections, treatments for certain eye conditions. Participants will either receive ice therapy (a topical ice compress) before their injection or no ice therapy, to determine any difference in pain levels. Candidates may qualify if they see a retina specialist at the University of Minnesota and require these specific eye injections. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance comfort during eye treatments.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that ice therapy is safe for injection site pain?

Research has shown that ice therapy is a safe and effective method for managing pain during injections. Studies have found that applying a cold compress before procedures, such as eye injections, can reduce pain and discomfort. Because this method does not involve medication, the risk of side effects remains low.

One study examined the safety and effectiveness of quickly cooling the area before injections and found it to be a practical way to manage pain. The study reported no major negative effects, indicating that ice therapy is generally safe. Additionally, research on very cold treatments, known as cryotherapy, has demonstrated its ability to reduce bruising and pain, further supporting the safety of this method.

Overall, these findings suggest that ice therapy is a safe option for reducing pain during injections, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ice therapy for injection site pain because it offers a simple and non-invasive way to potentially reduce discomfort. While current options for managing pain from injections often involve medications or topical anesthetics, ice therapy works by numbing the area, which might offer immediate relief without the need for drugs. This approach could be particularly appealing for those who prefer natural pain management techniques or who want to avoid the side effects of medications.

What evidence suggests that ice therapy is effective for reducing injection site pain?

Research has shown that ice therapy before an eye injection can reduce pain. In this trial, participants in the Ice-therapy arm will receive a cold ice patch before their injection, which studies have shown significantly lessens pain and makes the process easier to handle. Applying cold, such as an ice pack, has also effectively reduced pain, swelling, and inflammation in other medical situations. This suggests that ice therapy could be a simple and affordable way to make eye injections more comfortable. Overall, ice therapy appears to be a promising method to ease pain during these procedures. ^{2 3 6 7 8}

Who Is on the Research Team?

Jade Moon, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who need an anti-VEGF intravitreal injection for eye conditions, as determined by a retina specialist at the University of Minnesota Department of Ophthalmology. There are no specific exclusion criteria listed.

Inclusion Criteria

I am 18 or older and need an eye injection for my condition, as advised by a retina specialist.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravitreal anti-VEGF injections with or without pretreatment of topical ice-therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain, discomfort, burning, itching, and overall tolerability 24 hours after the injection

1 day

1 visit (virtual or phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Ice-therapy
• No Ice-therapy

Trial Overview

The study is testing if applying ice on the skin (topical ice-therapy) before getting an eye injection can reduce pain compared to not using any ice. Patients' pain experiences with and without ice will be compared.

How Is the Trial Designed?

Group I: Ice-therapy Active Control 1 Intervention

Ice therapy will be provided prior to the provision of the intravitreal injection

Group II: No Ice-therapy Placebo Group 1 Intervention

No ice therapy will be provided prior to the provision of the intravitreal injection

Ice-therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Topical Ice Compress for:

• Pain management for intravitreal injections

Approved in European Union as Ice Pack Therapy for:

• Pain relief for ocular procedures
• Local anesthesia for intravitreal injections

Approved in Canada as Cold Compress Therapy for:

• Pain management for eye injections
• Anesthesia for minor ocular surgeries

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 40 children aged 10 to 18, cold therapy using an ice pack prior to intramuscular injections did not significantly reduce perceived pain during the procedure.

However, the study found that distraction techniques and parental support were effective in alleviating pain, suggesting alternative strategies may be more beneficial for managing injection-related discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold therapy and its effect on procedural pain in children. Ebner, CA.[2019]

Cold therapy is an effective non-drug method for managing pain in small animals, influencing tissues and receptors to provide relief.

The review outlines specific indications and recommendations for using cold therapy, while also addressing its limitations in veterinary practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ice therapy: cool, current and complicated. Wright, B., Kronen, PW., Lascelles, D., et al.[2020]

In a study involving 50 children aged 8-10, cryoanesthesia using tetrafluorethane spray was found to significantly reduce pain perception compared to traditional topical anesthetic lidocaine, as measured by the visual analog scale (VAS).

While both methods showed lower pain scores, the objective assessment using the sound, eye, and motor (SEM) scale indicated that tetrafluorethane was effective in reducing discomfort, suggesting it could be a better alternative for managing pain during local anesthesia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of precooling the injection site using tetrafluorethane on pain perception in children. Hameed, NN., Sargod, SS., Bhat, SS., et al.[2022]

Applying an ice pack for 6 minutes before a digital nerve block significantly reduces both needle stick and infiltration pain scores in patients with traumatic finger injuries, with scores dropping from 6.8 to 1.5 and from 8.5 to 2.7, respectively.

Patients who received the ice treatment reported higher satisfaction levels, indicating that using ice is an effective and simple method to enhance comfort during painful procedures like digital nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment of ice pack effect in pain reduction during digital nerve block: A randomized clinical study. Rasooli, F., Sotoodehnia, M., Nejati, A., et al.[2020]

In a study of 36 patients undergoing skin grafts, the application of ice packs significantly reduced pain at the donor site compared to a control group, demonstrating an effective and low-cost pain management strategy.

Ice application was found to be safe and easy to use, providing substantial pain relief immediately after surgery, although no significant differences in pain levels were observed on days four and five post-operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ice application to minimize pain in the split-thickness skin graft donor site. Akan, M., Misirlioğlu, A., Yildirim, S., et al.[2008]

Applying ice to the injection site of corticosteroid injections in the hand and wrist does not significantly reduce post-injection pain compared to taking over-the-counter analgesics alone, based on a study of 68 patients.

In fact, more patients in the ice group reported an increase in pain after the injection, suggesting that ice application may not be beneficial for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial. An, TW., Boone, SL., Boyer, MI., et al.[2017]

This study will evaluate the effectiveness of ice packs at 0°C in reducing pain from vaccine injections compared to placebo cold packs at 10°C, involving 90 adult participants split into two groups.

The primary outcome will measure pain levels using a visual analogue scale, and the results could inform general practitioners on whether using ice packs is a beneficial practice to alleviate injection-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a randomised controlled trial of ice to reduce the pain of immunisation: The ICE trial. Ediriweera, Y., Banks, J., Hall, LM., et al.[2022]

Topical ice application on the palate before and during local injections can significantly reduce pain and discomfort for patients, making it a valuable technique for dental procedures.

This method is safe, well-accepted by patients (especially teenagers and adults), and effectively numbs the area by cooling the mucosa and affecting nerve sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical ice: a precursor to palatal injections. Harbert, H.[2008]

Cryotherapy, including methods like bagged ice and continuous cryotherapy devices, has been shown to reduce pain and analgesic consumption in about half of the studies reviewed, particularly after orthopedic surgeries, but its effectiveness in improving range of motion and reducing swelling is less clear.

Continuous cryotherapy devices appear to provide better outcomes in terms of pain reduction and recovery after knee arthroscopy compared to traditional ice methods, but more high-quality studies are needed to establish their superiority and safety as a standard treatment in orthopedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. Kunkle, BF., Kothandaraman, V., Goodloe, JB., et al.[2023]

Cooling the soft tissue at the injection site with ice significantly reduced pain perception in children undergoing local anesthesia for dental procedures, as measured by various pain assessment scales.

The effectiveness of ice pretreatment was consistent across different types of anesthesia (infiltration and block), indicating that this method can be a simple and effective way to manage pain in pediatric dental patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooling the soft tissue and its effect on perception of pain during infiltration and block anesthesia in children undergoing dental procedures: A comparative study. Bose, S., Garg, N., Pathivada, L., et al.[2020]

Ice has a strong short-term pain-relieving effect for various musculoskeletal conditions, supported by clinical experience, but scientific evidence from clinical trials is limited and fragmented.

Cryotherapy may work by several mechanisms, including reducing nerve conduction and muscle spasms, and preventing swelling, but more robust studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. Ernst, E., Fialka, V.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31305506/

An Open-Label Interventional Randomized Controlled Trial

Conclusion: Topical ice patch administered before intravitreal injection significantly decreased pain and overall tolerability. This simple and inexpensive ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05269823

NCT05269823 | Topical Ice-therapy for Intravitreal Injections

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3.

researchgate.net

researchgate.net/publication/334407942_REDUCTION_OF_POSTINTRAVITREAL_INJECTION_PAIN_USING_ICE_An_Open-Label_Interventional_Randomized_Controlled_Trial

An Open-Label Interventional Randomized Controlled Trial

Our aim in this study was to evaluate whether cooling the eye using topical ice compresses before intravitreal injection will reduce pain or ...

4.

mattioli1885journals.com

mattioli1885journals.com/index.php/aestheticmedicine/article/download/14810/11776/115286

Effectiveness of cold application on postoperative pain ...

Sarifakioglu et al. reported that injection pain significantly reduced on the side where the ice pack was applied19. The application of cold temperatures for ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S009917672030060X

The Effect of Soft Tissue Injury Cold Application Duration ...

Cold therapy was shown to be effective in decreasing pain, swelling, and inflammation in previous studies. Kuo et al14 tested the differences in pain, edema, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7541410/

Randomized Safety and Feasibility Trial of Ultra-rapid ...

To test the safety and preliminary efficacy of rapid, non-pharmacologic anesthesia via cooling for intravitreal injections.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352013217302569

The effect of cryotherapy application before versus after ...

Applying cryotherapy after injection was more effective in preventing hematoma formation and decreasing its size than applying it before injection.

8.

brieflands.com

brieflands.com/articles/jkums-110984

Effect of Localized Cold Compress on Pain Severity with ...

The present study aimed to evaluate the impact of topical cold compress on bruising and pain intensity at the subcutaneous injection site of enoxaparin.