Pharmacovigilance in Hospice/Palliative Care: Net Effect of Haloperidol for Nausea or Vomiting

J Palliat Med. 2018 Jan;21(1):37-43. doi: 10.1089/jpm.2017.0159. Epub 2017 Aug 3.

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.

Keywords: haloperidol; nausea; palliative care; pharmacovigilance; symptom control; vomiting.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antiemetics / therapeutic use*
  • Female
  • Haloperidol / therapeutic use*
  • Hospice and Palliative Care Nursing*
  • Humans
  • Male
  • Middle Aged
  • Pharmacovigilance*
  • Prospective Studies

Substances

  • Antiemetics
  • Haloperidol