Pharmacovigilance in hospice/palliative care: net effect of haloperidol for nausea or vomiting

Digges, Madeline; Hussein, Akram; Wilcock, Andrew; Crawford, Gregory B.; Boland, Jason W.; Agar, Meera R.; Sinnarajah, Aynharan; Currow, David C.; Johnson, Miriam J.

Abstract

Background: Haloperidol is widely prescribed as an antiemetic in patients receiving palliative care, but there is limited evidence to support and refine its use.

Objective: To explore the immediate and short-term net clinical effects of haloperidol when treating nausea and/or vomiting in palliative care patients.

Design: A prospective, multicenter, consecutive case series.

Setting/Subjects: Twenty-two sites, five countries: consultative, ambulatory, and inpatient services.

Measurements: When haloperidol was started in routine care as an antiemetic, data were collected at three time points: baseline; 48 hours (benefits); day seven (harms). Clinical effects were assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE).

Results: Data were collected (May 2014–March 2016) from 150 patients: 61% male; 86% with cancer; mean age 72 (standard deviation 11) years and median Australian-modified Karnofsky Performance Scale 50 (range 10–90). At baseline, nausea was moderate (88; 62%) or severe (11; 8%); 145 patients reported vomiting, with a baseline NCI CTCAE vomiting score of 1.0. The median (range) dose of haloperidol was 1.5 mg/24 hours (0.5–5 mg/24 hours) given orally or parenterally. Five patients (3%) died before further data collection. At 48 hours, 114 patients (79%) had complete resolution of their nausea and vomiting, with greater benefit seen in the resolution of nausea than vomiting. At day seven, 37 (26%) patients had a total of 62 mild/moderate harms including constipation 25 (40%); dry mouth 13 (21%); and somnolence 12 (19%).

Conclusions: Haloperidol as an antiemetic provided rapid net clinical benefit with low-grade, short-term harms.

Citation

Digges, M., Hussein, A., Wilcock, A., Crawford, G. B., Boland, J. W., Agar, M. R., …Johnson, M. J. (2018). Pharmacovigilance in hospice/palliative care: net effect of haloperidol for nausea or vomiting. Journal of Palliative Medicine, 21(1), 37-43. https://doi.org/10.1089/jpm.2017.0159

• Journal Article Type: Article
• Acceptance Date: Jun 20, 2017
• Online Publication Date: Aug 3, 2017
• Publication Date: Jan 1, 2018
• Deposit Date: Jan 22, 2018
• Publicly Available Date: Aug 4, 2018
• Journal: Journal of Palliative Medicine
• Print ISSN: 1096-6218
• Electronic ISSN: 1557-7740
• Publisher: Mary Ann Liebert
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Pages: 37-43
• DOI: https://doi.org/10.1089/jpm.2017.0159
• Keywords: Haloperidol; Nausea; Palliative care; Pharmacovigilance; Symptom control; Vomiting
• Public URL: https://nottingham-repository.worktribe.com/output/902156
• Publisher URL: https://doi.org/10.1089/jpm.2017.0159
• Additional Information: © 2018 Mary Ann Liebert, Inc. publishers All rights reserved. Final publication is available from Mary Ann Liebert, Inc., publishers http://dx.doi.org/10.1089/jpm.2017.0159
• Contract Date: Jan 22, 2018