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

Ediriweera, Yashodha, Banks, Jennifer, Hall, Leanne M., and Heal, Clare (2022) A study protocol for a randomised controlled trial of ice to reduce the pain of immunisation: The ICE trial. Australian Journal of General Practice, 51 (3). pp. 173-177.

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Background and objectives: Vaccine injections commonly cause iatrogenic pain. Ice may reduce pain. This is a study protocol for a prospective randomised controlled trial aiming to investigate the efficacy of ice packs to decrease vaccine-related pain in adults.

Methods: The intervention group (n = 45) will receive ice packs (0 °C) and the control group (n = 45) receive placebo cold packs (10 °C) on the injection site for 30 seconds prior to vaccination.

Results: The primary outcomes will test the hypothesis that applying an ice pack will significantly reduce pain of vaccination when compared with a cold pack. The primary dependent variable will be pain score recorded on a visual analogue scale. Secondary outcomes aim to assess potential adverse reactions. The main analysis of data will follow the intention-to-treat principle. The primary dependent variable will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis may be used.

Discussion: The trial may guide general practitioners in the use of ice packs to reduce injection-related pain in adults.

Item ID: 76529
Item Type: Article (Scholarly Work)
ISSN: 2208-7958
Copyright Information: © The Royal Australian College of General Practitioners 2022.
Date Deposited: 23 Feb 2023 04:43
FoR Codes: 42 HEALTH SCIENCES > 4299 Other health sciences > 429999 Other health sciences not elsewhere classified @ 100%
SEO Codes: 20 HEALTH > 2003 Provision of health and support services > 200310 Primary care @ 100%
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