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Use of a cooling pack to reduce subcutaneous vaccine injection pain in children aged 3-6 years: A single-blind,
Ikuo Okafuji1, Ryuta Washio2, Takao Okafuji3
1Department of Pediatrics, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Insights
Local cooling effectively reduces pain during childhood vaccinations. This simple method improves comfort for children aged 3-6 years receiving vaccines like Japanese encephalitis or influenza.
Area of Science:
- Pediatric medicine
- Pain management
- Vaccination techniques
Background:
- Evidence-based pain relief methods for pediatric vaccinations exist but are often labor-intensive.
- Routine clinical application of these pain management strategies is limited.
Purpose of the Study:
- To assess the safety and efficacy of local cooling for pain reduction during subcutaneous vaccine injections in young children.
- To provide a practical, easily implementable pain relief option for pediatric vaccinations.
Main Methods:
- A single-blind, randomized, multicenter study involving 60 preschool children (aged 3-6 years) undergoing vaccination.
- Participants were assigned to a local cooling group (cooling pack before injection) or a control group.
- Pain was measured using the FLACC scale (Facial expression, Leg movement, Activity, Crying, Consolability) via video analysis.
Main Results:
- The cooled group showed significantly lower median FLACC pain scores (1 [IQR 0-1.25]) compared to the non-cooled group (2.5 [IQR 1-6]), P=0.011.
- No adverse effects associated with the local cooling method were reported.
- The study included vaccinations for Japanese encephalitis and influenza.
Conclusions:
- Local cooling is a safe and effective intervention for reducing pain in children aged 3-6 years during subcutaneous vaccine administration.
- This technique offers a practical approach to enhance patient comfort during routine immunizations.
Background:
There are many evidence-based treatments available for pain-relief during subcutaneous vaccine injection in children. However, these methods are commonly labor-intensive and not routinely applied in clinical settings.
Objectives:
To evaluate the safety and pain-relieving effect of local cooling during subcutaneous vaccine injection in young children.
Method:
This single-blind, randomized, parallel-group multicenter study was conducted at two pediatric clinics in Hyogo Prefecture, which included preschool children aged 3-6 years scheduled for vaccination against Japanese encephalitis or influenza virus. Participants were randomly assigned to either the cooled group (local cooling applied using a cooling pack before vaccination) or the non-cooled group (provided with a room temperature cooling pack). Randomization was performed using a computer-generated block method. The primary endpoint was infant pain, measured using the FLACC scale (Facial expression, Leg movement, Activity, Crying, Consolability), rated by a third-party reviewing videos of the vaccination process.
Results:
A total of 60 children were randomized into the cooling (n = 30) and non-cooling (n = 30) groups, with all participants completing the study. Fifty-four participants received the Japanese encephalitis vaccine, and six received the influenza vaccine. Demographic data, including age, sex, and vaccine type, did not differ significantly between the two groups. The median FLACC score in the cooled group was significantly lower (1 [IQR 0-1.25]) compared to the non-cooled group (2.5 [IQR 1-6]) (P = 0.011). No adverse effects related to cooling were observed.
Conclusion:
Local cooling during subcutaneous vaccine administration is a safe and effective method to reduce pain in children aged 3-6 years. This method can be easily implemented in routine vaccinations to improve patient comfort.
Trial Registration:
Japan Registry of Clinical Trials, jRCTs052200149, Mar 09, 2021, https://jrct.niph.go.jp/en-latest-detail/jRCTs052200149.
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