Psychological responses to the needle-free Medi-Jector or the multidose Disetronic injection pen in human growth hormone therapy.

The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi-Jector results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi-Jector is a needle-free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two-period cross-over trial. A questionnaire was used to assess psychological responses such as non-compliance, opinion on ease of preparation, affective responses to administration and local side-effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi-Jector less offputting (p < 0.01), less painful with respect to both frequency (p < 0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p < 0.01). No difference in compliance was detected. Most subjects preferred the Medi-Jector for future use (p < 0.05). The mean score on a 1-10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi-Jector and 6.8 (SD 2.3) for the multidose injection pen (p < 0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi-Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi-Jector (p < 0.06). It is concluded that use of the Medi-Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles.

RCT Entities:   Population Interventions Outcomes