Effectiveness of skin icing in reducing pain associated with goserelin acetate injection

Kinoshita, Hidefumi; Kawa, Gen; Hiura, Yoshihito; Chizaki, Ryusuke; Matsuda, Tadashi

doi:10.1007/s10147-010-0095-0

Cited by 9 publications

(13 citation statements)

References 5 publications

(9 reference statements)

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“…While other implant forms of LHRH agonists may result in substantial (albeit tolerable) pain on injection in some patients [Kinoshita et al 2010], very few injection-site reactions were recorded in the comparator-controlled studies reported here. Further evidence for the good tolerability of the leuprorelin implants is available from two large post-marketing surveillance studies.…”

Section: Discussionmentioning

confidence: 74%

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Geiges¹,

Schapperer

Thyroff-Friesinger

et al. 2012

Therapeutic Advances in Urology

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Objectives: Two innovative pharmaceutical forms of leuprorelin acetate have been developed as 1-month and 3-month implants for the treatment of advanced hormone-dependent prostate cancer. These products contain active substance dispersed homogeneously in a biodegradable polymer. Here we present the key results from the clinical development of these slow-release implant formulations of leuprorelin. Methods: Two therapeutic studies of the 1-month implant were performed: a randomized, controlled study comparing the leuprorelin implant with leuprorelin prolonged-release microspheres (Enantone) as the active control; and a single-arm study of the leuprorelin implant. For the 3-month implant, four therapeutic studies were performed: a randomized, controlled study comparing the leuprorelin implant with leuprorelin prolonged-release microspheres (Trenantone) as the active control; a single-arm study of the leuprorelin implant; and two long-term studies with the 3-month implant administered twice, either 12 or 16 weeks apart. A pooled analysis of data from the comparator-controlled and single-arm studies of the 3-month implant was also conducted. The main inclusion criterion for all studies was histologically confirmed advanced prostate cancer, with primary endpoints based around successful testosterone suppression (≤0.5 ng/ml). Results: In the comparator-controlled studies, both implants were as effective as the microspheres for achieving successful testosterone suppression and normalization of prostate-specific antigen (PSA) levels. Data from the single-arm and long-term studies were consistent with those from the comparator-controlled studies. In the pooled analysis, significantly more patients treated with the 3-month implant achieved successful testosterone suppression compared with the comparator ( p ≤ 0.01). The safety profile of the implants in the comparator-controlled studies was similar to that of the prolonged-release microsphere formulation, and consistent with that of the luteinizing hormone-releasing hormone agonist class. Conclusions: The innovative 1-month and 3-month implants of leuprorelin acetate are at least as effective as leuprorelin acetate prolonged-release microspheres for achieving successful testosterone suppression and normalization of PSA in men with advanced hormone-dependent prostate cancer, with a comparable safety profile.

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Section: Discussionmentioning

confidence: 74%

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Geiges¹,

Schapperer

Thyroff-Friesinger

et al. 2012

Therapeutic Advances in Urology

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“…In those studies, the injection pain was tolerable for most Caucasian patients and their mean VAS score was 13 mm. As Kinoshita et al [11] reported, the mean VAS score (32.4 mm) in Japanese patients was higher than that in Caucasian patients. In the present study, the mean VAS score with the routine method was 32.7 mm, a result similar to that of Kinoshita et al The difference between Caucasian and Japanese patients may be explained by the difference in abdominal subcutaneous fat thickness.…”

Section: Discussionmentioning

confidence: 84%

“…Recently, the efficacy of skin icing to reduce pain associated with goserelin injection was reported [11]. However, to our knowledge, there have been no reports on the optimal duration of skin icing before goserelin acetate injection.…”

Section: Introductionmentioning

confidence: 83%

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Fifteen-Second Skin Icing Using a Frozen Gel Pack Is Effective for Reducing Goserelin Injection Pain

Naya

Hagiwara²,

Takeuchi³

et al. 2013

Urol Int

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Objective: The efficacy of skin icing to reduce the pain of goserelin injection has been reported. We investigated the optimal icing time with a frozen gel pack and its effectiveness. Methods: Abdominal skin temperatures of 49 healthy volunteers were measured after application of the frozen gel pack for 10, 15 and 30 s, and it was decided that a 15-second icing was adequate. For 55 consecutive patients who received goserelin (10.8 mg) injection, pain was evaluated employing a visual analog scale (VAS). The first injection was administered routinely. A second injection was administered after skin icing in 27 of 55 patients who wanted to try icing. At the time of the third injection, all patient decided whether they were to receive icing or the routine method. Results: After icing, VAS scores decreased in 20 of 27 patients. At the third injection, 18 patients requested icing. Conclusion: When a patient complains of injection pain, the icing method should be considered for pain reduction.

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“…The use of icing or cooling the skin is the most commonly reported intervention to reduce pain, and is being used prior to various interventions, such as physical therapy, laser treatment, and minor surgical procedures. The use of skin cooling has been reported to be successful in reducing pain from various injections, such as goserelin, 5 local anesthesia, botulinum toxin, and intralesional steroid injection, [6][7][8][9][10] local anesthesia injections during dental procedures, 11 and heparin injections. 12 Other reported methods include vibration anesthesia.…”

Section: Original Researchmentioning

confidence: 99%

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

et al. 2017

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Effectiveness of skin icing in reducing pain associated with goserelin acetate injection

Abstract: Icing at the injection site of goserelin acetate is a safe and effective method to reduce injection pain. This method can be easily performed in daily practice if a patient complains of pain at the injection site.

Cited by 9 publications

References 5 publications

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Clinical development of two innovative pharmaceutical forms of leuprorelin acetate

Fifteen-Second Skin Icing Using a Frozen Gel Pack Is Effective for Reducing Goserelin Injection Pain

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

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