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

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.

Australian Journal of General Practice

Australian Journal of General Practice

51

2208-7958

N/A

3

5