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Droperidol
See also Neuroleptic drugs
General information
Droperidol is a butyrophenone with actions similar to those of haloperidol.
Of 20 volunteers who took droperidol 5 mg orally in orange juice, none had a neutral or pleasant experience [ ]. All reported restlessness, 17 felt sedated, and 11 reported dysphoria, the onset being relatively immediate; one subject broke down in tears within an hour of taking droperidol. Suicidal feelings emerged acutely in two subjects and were entertained in two more subjects. Among other adverse events were skin hypersensitivity (n = 5), aching in the muscles (n = 6), wheezing consistent with respiratory dyskinesia (n = 1), change in voice quality (n = 1), and marked rhinorrhea (n = 1). Mental effort was difficult, and all subjects reported some problems with concentration.
Droperidol 5–7.5 mg given during induction of anesthesia was associated with impaired well-being scores 6 hours postoperatively in a randomized double-blind comparison of similar doses of droperidol (n = 78) and midazolam (n = 72) for preventing postoperative nausea and vomiting [ ].
With regard to the benefit to harm balance of the use of droperidol as an antiemetic, it has been suggested that the acceptable risk for antiemetic drug administration be established and that prospective data be collected to establish the risk associated not only with the administration of droperidol but also with other commonly used antiemetics [ ]. However, according to the FDA [ ], a causal relation between the drug and an adverse effect need not be established, and reasonable evidence of an association requires including a warning in the drug labelling.
Drug studies
Comparative studies
Prophylactic intravenous droperidol (10, 20, 40, or 80 micrograms/kg) dose-dependently reduced postoperative nausea and vomiting without increasing the time to discharge in 82 children who underwent strabismus surgery [ ]. There were no particular adverse effects, but sedation scores were higher in those who received the higher doses.
In contrast, the addition of droperidol (2.5 mg bd for 5 days) to granisetron (3 mg bd on the first day) and dexamethasone (16 mg bd on the first day, 8 mg bd on days 2 and 3, and 4 mg bd on days 4 and 5) did not reduce the delayed emesis induced by high-dose cisplatin in a double-blind, randomized, parallel study in 180 patients with lung cancer receiving chemotherapy [ ]. The incidence of sleepiness with droperidol was higher (69% versus 30%). A meta-analysis of 33 trials, with data from 3447 patients, showed that when only two drugs were used (a 5-HT3 receptor antagonist plus either droperidol or dexamethasone), both were similar and significantly more effective than the 5-HT3 antagonist alone for prophylaxis of postoperative nausea and vomiting [ ]. Adverse effects were reported in seven studies involving the combination with droperidol and in 13 studies involving the combination with dexamethasone. The most commonly reported adverse effects were dizziness, headache, and drowsiness and the incidences were not different across the groups.
Placebo-controlled studies
In a randomized, double-blind, dose-ranging study in 305 adults receiving droperidol 0.1, 2.75, 5.5, and 8.25 mg for the acute treatment of migraine, the number of patients who achieved a pain-free response at 2 hours after treatment was significantly greater than with placebo for droperidol 2.75, 5.5, and 8.25 mg [ ]. The most frequent adverse events were akathisia and weakness, and adverse events were dose related. Anorexia, anxiety, somnolence, tremor, and confusion were also reported. No patient had QT interval prolongation.
In a randomized, placebo-controlled trial in 140 patients a combination of metoclopramide 10 mg and droperidol 1.25 mg or two doses of droperidol provided a more effective antiemetic effect than metoclopramide alone [ ]. The level of sedation was significantly greater in the patients who received two doses of droperidol (8/35) and metoclopramide followed by droperidol (7/35) than in those who received only placebo (0/35) or metoclopramide followed by placebo (0/35).
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