The Antiemetic Efficacy of Droperidol Added to Morphine Patient-Controlled Analgesia: A Randomized, Controlled, Multicenter Dose-Finding Study

Abstract

The antiemetic dose response of droperidol when it is added to patient-controlled analgesia with morphine is not well known. We randomly allocated adults who received postoperative morphine patient-controlled analgesia (1-mg bolus, 5-min lockout) to one of four regimens: no droperidol (control) or 5, 15, or 50 micro g of droperidol per milligram of morphine. Efficacy and adverse effects were recorded during 24 h and were analyzed with number needed to treat (NNT) and number needed to harm with 95% confidence intervals. Data from 82 controls, 82 patients receiving droperidol 5 micro g, 82 receiving droperidol 15 micro g, and 83 receiving droperidol 50 micro g were analyzed. Average consumption of droperidol per 24 h was 0.2 mg with the 5- micro g regimen, 0.61 mg with the 15- micro g regimen, and 2.04 mg with the 50- micro g regimen. In controls, the incidence of nausea was 48.8%; with droperidol 5 micro g, it was 42.7% (NNT compared with control, 16 [95% confidence interval, 4.7 to -11]); with 15 micro g, it was 32.9% (NNT, 6.3 [3.3-100]); and with 50 micro g, it was 21.7% (NNT, 3.7 [2.4 to 7.6]). In controls, the incidence of vomiting was 24.4%; with droperidol 5 micro g, it was 23.2% (NNT compared with control, 82 [7 to -8.5]); with 15 micro g, it was 22.0% (NNT, 41 [6.5 to -9.6]); and with 50 micro g, it was 12% (NNT, 8.1 [4.2-142]). In controls, the incidence of pruritus was 12.2%; with droperidol 5 micro g, it was 6.1% (NNT compared with control, 16 [6.7 to -37]); and with 15 and 50 micro g, it was 2.4% (NNT, 10 [5.7-52]). In controls, the incidence of sedation was 2.4%; with droperidol 5 micro g, it was 8.5% (number needed to harm (NNH) compared with control, 16 [7.7 to -123]); with 15 micro g, it was 6.1% (NNH, 27 [10 to -40]); and with 50 micro g, it was 18.1% (NNH, 6.4 [4.1-15]). There were no extrapyramidal symptoms and no cardiac adverse events. There was no difference in patient satisfaction. The optimal antiemetic dose of droperidol is 15-50 micro g/mg of morphine. Larger doses may have more antivomiting efficacy but are likely to be unacceptably sedating.

Evidence-based management of postoperative nausea and vomiting: a review

“…32 In this setting, the optimal antiemetic dose of droperidol was 15 to 50 µg·mg -1 of morphine (IIIA). 61 Sedation and drowsiness are important side effects of droperidol and are dose dependent. Low doses of droperidol (0.625-1.25 mg) were not associated with any increased sedation compared to ondansetron 4 mg (IA).…”

Náuseas e vômitos no pós-operatório: uma revisão do "pequeno-grande" problema

“…Quando se utilizam esquemas analgésicos com morfina, controlados pelo paciente, este parece ser o antiemético mais eficaz. As doses entre 15 e 50 µg de droperidol por mg de morfina são as que apresentam melhor relação eficácia/efeitos colaterais 32 34 . Não é aconselhável em idosos e tem como limitação o início de ação tardio (2 a 4 horas após a sua administração) 35 .…”

“…In morphine patient-controlled analgesia this seems to be the most effective antiemetic drug. Doses between 15 and 50 µg droperidol per mg of morphine are those with best efficacy/side effects ratio 32 . In 2001, the Food and Drug Administration has published a warning about the association of droperidol in patients with prolonged QT interval at ECG and/or Torsade de Pointes, which in some cases has resulted in arrhythmias and death.…”

Recomendaciones de prevención y tratamiento de las náuseas y vómitos postoperatorios y/o asociados a las infusiones de opioides

“…La analgesia controlada por el paciente (PCA) es una forma de proporcionar analgesia optimizada de forma individualizada y permitir una rápida movilización de los pacientes tras cirugía. Varios ensayos clínicos han demostrado una incidencia de NVPO mayor del 50% durante el tratamiento de PCA con morfina (64,100). En un estudio español en el que se usaron dosis bajas de morfina, inferiores en un 40% al estándar debido al empleo de un método de analgesia multimodal, las NVPO afectaban al 19,8% de los pacientes (101).…”

“…Un trabajo reciente en pacientes adultos que recibieron morfina con PCA (1 mg en bolo, con bloqueo de 5 min) demostró que la dosis antiemética óptima de droperidol oscila entre 15 y 50 µg (NNT 6,3 y 3,7 para náuseas y 27 y 6,4 para vómitos respectivamente). Dosis mayores pueden tener más eficacia antiemética pero pueden provocar sedación: 15 µg de droperidol muestran eficacia antiemética y antiprurítica sin provocar sedación; droperidol 50 µg es un antiemético potente, pero no más antiprurítico que 15 µg y tiene efecto sedante (100). Otro trabajo demostró que la coadministración de 50 µg de droperidol y 1 mg de morfina a demanda vía PCA proporciona un ahorro en la necesidad de morfina y reduce la frecuencia de NV (112).…”