Ice Therapy for Injection Site Pain

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

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.

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.

Is ice therapy safe for reducing pain at injection sites?

Ice therapy is generally considered safe for reducing pain at injection sites, as it has been used for many years to manage pain in various conditions. However, scientific evidence on its effectiveness is mixed, and it is important to follow recommended guidelines for its use. ^{1 2 3 4 5}

How does ice therapy differ from other treatments for injection site pain?

Ice therapy is unique because it uses cold to numb the skin and reduce pain at the injection site, which is different from traditional methods like topical anesthetics that can have a longer duration and unpleasant taste. This method is simple, safe, and effective, especially for children and anxious patients. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment Ice-therapy for reducing injection site pain?

Research shows that applying ice packs can effectively reduce pain during procedures like digital nerve blocks and skin grafts, making it a convenient and low-cost option for pain relief. ^{5 7 9 10 11}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. India pubmed.ncbi.nlm.nih.gov

The assessment of ice pack effect in pain reduction during digital nerve block: A randomized clinical study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Effectiveness of precooling the injection site using tetrafluorethane on pain perception in children. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ice application to minimize pain in the split-thickness skin graft donor site. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial. [2017]

6. Australia pubmed.ncbi.nlm.nih.gov

A study protocol for a randomised controlled trial of ice to reduce the pain of immunisation: The ICE trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Ice therapy: cool, current and complicated. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Iran 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. [2020]