Prospective real-time evaluation of the QTc interval variation after low-dose droperidol among emergency department patients.

OBJECTIVE: To assess the QTc interval variation after low-dose droperidol in a population of undifferentiated, stable, and non-agitated patients receiving droperidol in the emergency department. METHODS: Prospective cohort study of patients aged ≥12 years of age who received low-dose droperidol (≤ 2.5 mg) for indications other than acute behavioral disturbances. QTc intervals were monitored in real-time during pre-specified observation periods in the ED. Primary outcome was variation of QTc interval after droperidol administration, defined as the maximum delta (change) of QTc interval. Other outcomes included proportion of patients with a QTc ≥ 500 ms after droperidol, delta ≥ +60 ms, and incidence of clinical adverse events. Patients were monitored up to 30 min after IV bolus and up to 46 min after infusion. RESULTS: A total of 68 patients were included (mean age 42.1 years, 66.2% females). The median dose of droperidol was 1.875 mg (range 0.625 mg, 2.5 mg) and 94.1% received droperidol for headache management. Most patients received droperidol as a 2-min bolus (n = 41, 60.3%). The mean maximum delta of QTc interval after droperidol across all 68 patients was +29.9 ms (SD 15). A total of 12 patients (17.6%) experienced a QTc interval ≥ 500 ms during the observation period after droperidol, and 3 patients (4.4%) had a delta QTc ≥ +60 ms. There were no serious arrhythmias, such as TdP, or deaths among the 68 participants in this study (0/68). However, 13.2% (n = 9) had at least one non-serious adverse event including restlessness and/or anxiety. CONCLUSION: The QTc interval slightly increased after droperidol administration, but these prolongations were brief, mostly below 500 msec and did not lead to serious arrhythmias. The yield of continuous cardiac monitoring in patients receiving low doses of droperidol is likely low.

Emergency medicine updates: Droperidol.

INTRODUCTION: Droperidol is a butyrophenone that has recently been reintroduced after a United States Food and Drug Administration (US FDA) black box warning in 2001. Evidence demonstrates utility in a variety of clinical conditions. OBJECTIVE: This paper provides evidence-based updates concerning the use of droperidol for the emergency clinician. DISCUSSION: Droperidol received a black box warning by the US FDA in 2001 due to concerns for QT prolongation and torsades de pointes; however, reevaluation of the available data suggests droperidol is a safe and efficacious medication. It can be used in the emergency department (ED) setting for many conditions, including acute agitation, headaches, vertigo, nausea, and vomiting. Extensive literature supports that the QT-prolonging effects are transient and that the risk of torsades de pointes is rare with doses utilized in the ED. An electrocardiogram does not need to be routinely obtained before droperidol use but should be considered in patients at high risk for QT prolongation. CONCLUSIONS: Current evidence suggests that droperidol is a safe and effective medication for treating nausea and vomiting, headache, vertigo, and agitation in the ED setting.

Droperidol Reduces Postoperative Nausea and Vomiting and Supports the Continuation of Intravenous Patient-Controlled Analgesia with Fentanyl.

PURPOSE: To examine the impact of adding droperidol to fentanyl-based intravenous patient- controlled analgesia (IVPCA) on the discontinuation of IVPCA use due to postoperative nausea and vomiting (PONV). METHODS: Patients who underwent surgeries other than abdominal surgeries and used IVPCA between April 2014 and March 2018 were selected. Patients using IVPCA with fentanyl alone were compared to patients using droperidol added to IVPCA. Patients were allocated to one of two groups depending on the drug used for IVPCA: 1) control group, fentanyl alone; 2) droperidol group, droperidol with fentanyl. The primary endpoint was the discontinuation of IVPCA due to PONV. Secondary endpoints included PONV within 48 hours after surgery, the number of antiemetics used, pain score, and adverse effects. Propensity score matching was used to control the differences in clinical features among patients. RESULTS: Among the 793 patients initially enrolled in this study, 145 were excluded via propensity score matching; 364 of the remaining patients received IVPCA supplemented with droperidol. Propensity score matching showed that discontinuation of IVPCA due to PONV was significantly decreased in the droperidol group compared to the control group (P = 0.01). Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01). CONCLUSIONS: The addition of droperidol to IVPCA is associated with a decrease in PONV, as well as the improved continuation of pain treatment with fentanyl-based IVPCA, similar to IVPCA with morphine. However, it is necessary to monitor the side effects of this treatment.

Rescue Sedation When Treating Acute Agitation in the Emergency Department With Intramuscular Antipsychotics.

BACKGROUND: Rapid treatment of agitation in the emergency department (ED) is critical to avoid injury to patients and providers. Treatment with intramuscular antipsychotics is often utilized, but there is a paucity of comparative effectiveness evidence available. OBJECTIVE: The purpose of this investigation was to compare the effectiveness of droperidol, olanzapine, and haloperidol for treating agitation in the ED. METHODS: This was a retrospective observational study of adult patients who received intramuscular medication to treat agitation. Patients were classified based on the initial antipsychotic they received. The primary effectiveness outcome was the rate of additional sedation administered (rescue medication) within 1 h. Secondary outcomes included rescue sedation for the entire encounter and adverse events. RESULTS: There were 15,918 patients included (median age 37 years, 75% male). Rescue rates at 1 h were: 547/4947 for droperidol (11%, 95% confidence interval [CI] 10-12%), 988/8825 olanzapine (11%, 95% CI 10-12%), and 390/2146 for haloperidol (18%, 95% CI 17-20%). Rescue rates for the entire ED encounter were: 832/4947 for droperidol (17%, 95% CI 16-18%), 1665/8825 for olanzapine (19%, 95% CI 18-20%), and 560/2146 for haloperidol (26%, 95% CI 24-28%). Adverse events were uncommon: intubation (49, 0.3%), akathisia (7, 0.04%), dystonia (5, 0.03%), respiratory arrest (1, 0.006%), and torsades de pointes (0), with no significant differences between drugs. CONCLUSIONS: Olanzapine and droperidol lead to lower rates of rescue sedation at 1 h and overall, compared with haloperidol. There were no significant differences in major adverse events.

Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial.

BACKGROUND: Akathisia, a distressing movement disorder induced by butyrophenones, has been described with low doses of droperidol used for postoperative nausea and vomiting (PONV) prophylaxis, but the incidence remains unclear. OBJECTIVES: To determine the incidence of akathisia after PONV prophylaxis with two doses of droperidol in comparison with ondansetron, in patients undergoing ambulatory surgery. We hypothesised that the incidence of akathisia is higher with droperidol than that with ondansetron. DESIGN: Randomised controlled double blind trial. SETTING: Two University Hospital Centres and two private Clinics from January to September 2014. PATIENTS: Patients (n=297) undergoing general anaesthesia for ambulatory surgery were randomly allocated to receive PONV prophylaxis with droperidol (0.625 or 1.25 mg) or ondansetron 4 mg; patients of the three groups also received 4 mg of dexamethasone. Exclusion criteria were contraindication to droperidol and ondansetron, use of psychotropic medications or benzodiazepines or history of psychotic illness. INTERVENTIONS: Participants received droperidol (0.625 or 1.25 mg) or ondansetron 4 mg during general anaesthesia. After discharge from the postanaesthesia care unit presence and severity of akathisia were assessed using the Barnes Akathisia Rating Scale at 4 h postoperatively. MAIN OUTCOME MEASURES: Score of the Global Clinical Assessment of Akathisia of Barnes Akathisia Rating Scale. RESULTS: The number of akathisia observed was 1/118 (0.8%) in the ondansetron group, 1/84 (1.2%) in droperidol 0.625 mg group, and 3/87 (3.4%) in droperidol 1.25 mg group. The akathisia rate difference among the three groups was not significant (P = 0.52). We could not demonstrate significant differences in the incidence of akathisia between the two doses of droperidol. The only case of marked akathisia treated with benzodiazepines was observed after droperidol 1.25 mg. CONCLUSION: The use of droperidol or ondansetron for PONV prophylaxis is associated to a low incidence of akathisia (0.8 to 3.4%) after general anaesthesia for ambulatory surgery. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01942343.

A randomised controlled trial of placebo, droperidol or ondansetron to prevent nausea and vomiting after tonsillectomy in children receiving dexamethasone.

We tested whether prophylactic droperidol and ondansetron, in combination with a moderate dose of dexamethasone, were equally effective in reducing nausea and vomiting after tonsillectomy in children and that both were superior to saline with dexamethasone. We randomly allocated 300 children to intravenous saline, droperidol 10 µg.kg-1 or ondansetron 150 µg.kg-1 , after induction of anaesthesia and the administration of intravenous dexamethasone 250 µg.kg-1 . The rates (95%CI) of nausea or vomiting within 24 postoperative hours were: 42/91 after saline, 46% (36%-57%); 43/87 after droperidol, 49% (39%-60%); reduced to 18/84 by ondansetron, 21% (13%-32%), p < 0.001. There were no differences in the rates of side-effects between groups. We conclude that ondansetron is more effective than saline in preventing nausea or vomiting after paediatric tonsillectomy when given with a moderate dose of dexamethasone, whereas droperidol was not.

[Involuntary Movement of Bilateral Lower Limbs Caused by Epidural Anesthesia: A Case Report].

Regional anesthesia, especially epidural anesthesia, rarely causes involuntary movement Here we present a case of a patient who demonstrated myoclonus-like involuntary movement of the lower limbs during continuous infusion of ropivacaine, fentanyl, and droperidol through the thoracic epidural catheter. This movement disappeared when the epidural infusion was stopped, but reappeared when the epidural infusion was restarted. Naloxone did not eliminate the movement The patient was thereafter discharged uneventfully. This case and other reports in the literature suggest that involuntary movement associated with regional anesthesia is rare and self-limiting. However, careful consideration should be given to exclude other, potentially dangerous complications.

Droperidol v. haloperidol for sedation of aggressive behaviour in acute mental health: randomised controlled trial.

BACKGROUND: Agitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients. AIMS: To compare the effectiveness and safety of haloperidol v. droperidol for patients with agitation and aggression. METHOD: In a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries. RESULTS: From 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15-30, range 10-75) for haloperidol v. 25 min (IQR 15-30, range 10-115) for droperidol (P = 0.89). Additional sedation was used more often with haloperidol (13% v. 5%, P = 0.06), but adverse effects were less common with haloperidol (1% v. 5%, P = 0.12). There were 8 staff injuries. CONCLUSIONS: Both haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

Small doses of droperidol do not present relevant torsadogenic actions: a double-blind, ondansetron-controlled study.

AIM: Drugs used for postoperative nausea and vomiting prophylaxis are believed to provoke torsadogenic changes in cardiac repolarization. The aim of this study was to assess the effect of small doses of droperidol on the parameters of cardiac repolarization, including the QTc interval and transmural dispersion of repolarization. METHODS: A total of 75 patients were randomly allocated to receive 0.625 or 1.25 mg droperidol or 8 mg ondansetron. The QTc interval was calculated using Bazett's formula and the Framingham correction. The transmural dispersion of repolarization was determined as Tpeak -Tend time. RESULTS: Transient QT prolongation, corrected with both formulae, followed 1.25 mg of droperidol 10 min after administration. No change in the QTc value was observed in the other groups. When corrected with Bazett's formula, QTc was prolonged above 480 ms in two patients receiving 1.25 mg droperidol (at the 10(th) and 20(th) minute of the study) and in one receiving ondansetron. No patients developed a QTc B prolongation over 500 ms. No increase above 480 ms was observed relative to the Framingham correction method. There were no significant differences in the Tpeak -Tend time either between or within the groups. CONCLUSION: In men without cardiovascular disorders small doses (1.25 mg) of droperidol prophylaxis induced transient QTc prolongation without changes in transmural dispersion of repolarization. The apparently low risk of the drug applies only in low risk male patients with a low pro-QTc score.

The Safety and Effectiveness of Droperidol for Sedation of Acute Behavioral Disturbance in the Emergency Department.

STUDY OBJECTIVE: We investigate the safety and effectiveness of droperidol for sedation of acute behavioral disturbance in the emergency department (ED). METHODS: This was a prospective observational study in 6 EDs (August 2009 to April 2013). Adult patients requiring parenteral sedation for acute behavioral disturbance received droperidol 10 mg. If this did not sedate the patient within 15 minutes, further sedation was allowed but droperidol 10 mg was recommended as part of a sedation protocol. The primary outcome was the proportion of patients with an abnormal QT interval, defined by the at-risk line on the QT nomogram. Secondary outcomes were effectiveness determined by the time to sedation measured on the Sedation Assessment Tool, use of additional sedation, adverse events, and injury to staff or patients. RESULTS: There were 1,009 patients with an ECG performed within 2 hours of droperidol administration, with a median dose of 10 mg (interquartile range [IQR]10 to 17.5 mg). Thirteen of the 1,009 patients had an abnormal QT (1.3%; 95% confidence interval 0.7% to 2.3%), but 7 of these had another cause attributed for prolonged QT (methadone, escitalopram, amiodarone, or preexisting). In 1,403 patients sedated with a median total dose of droperidol of 10 mg (IQR 10 to 20 mg), the median time to sedation was 20 minutes (IQR 10 to 30 minutes) and 97% were sedated within 120 minutes. Additional sedation was required for 435 patients (31.0%; 95% confidence interval 28.6% to 33.5%). Adverse events occurred in 70 patients (5%) and oversedation without complications in 109 (8%), the latter more common for patients receiving benzodiazepines as additional sedation (16/109 [15%]). There were no cases of torsades de pointes. Injuries occurred in 34 staff members and 4 patients. CONCLUSION: The study supports the use of high-dose droperidol as a safe sedating agent for patients with acute behavioral disturbance in the ED. There is no evidence of increased risk for QT prolongation with the doses used in this study.

Droperidol for the treatment of acute migraine headaches.

OBJECTIVE: To evaluate the safety and efficacy of droperidol for the relief of acute migraine headaches. DATA SOURCES: A MEDLINE search (1946 to August 2014) was performed using the following keywords and associated medical subject headings: droperidol, inapsine, headache, migraine, and migraine disorder. STUDY SELECTION AND DATA EXTRACTION: The search was conducted to identify randomized controlled trials comparing droperidol with placebo or an active control in adult patients with acute migraine headaches that were published in English. Primary end points included acute headache improvement after the intervention. Safety end points included the frequency of extrapyramidal symptoms, somnolence, and cardiac adverse effects. DATA SYNTHESIS: In all, 5 manuscripts are included in this review. Patients presenting to the emergency department with acute headache desire rapid pain relief, which was the primary objective in each of the evaluated studies. Droperidol was better than placebo and at least as effective as comparator drugs such as prochlorperazine, meperidine, or olanzapine using droperidol doses of 2.5 to 5 mg, given either intramuscularly (IM) or intravenously (IV). The most commonly reported adverse effects were extrapyramidal symptoms and sedation. Cardiac adverse effects were not reported in any of the studies; however, only 2 articles described using cardiac monitoring. CONCLUSIONS: Parenteral droperidol is an effective option for the treatment of acute migraine. The minimum effective dose is 2.5 mg given IM or IV. Clinicians must be aware of the risk for adverse events, select appropriate patients, perform EKG monitoring for patients at risk of QTc prolongation, and institute treatment if necessary.

Droperidol transiently prolongs the QT interval in children undergoing single ventricle palliation.

Historically, droperidol was commonly used for postoperative sedation of critically ill children. A FDA black box warning regarding its arrhythmogenic potential greatly reduced its use. We hypothesized that administration of neuroleptic dose droperidol during volatile anesthesia would transiently prolong the corrected QT interval (QTc) in patients undergoing single ventricle palliation. As part of a prospective study in children undergoing stage 2 or 3 single ventricle palliation, we recorded electrocardiograms preoperatively, after induction of volatile anesthesia, immediately after completion of 30 min intravenous infusion of 75 mcg/kg droperidol, and shortly after arrival in the cardiac intensive care unit. Mean absolute QT intervals and heart rate data were analyzed in a blinded fashion and the longest QT interval was determined. QT intervals were corrected for heart rate (QTc) with the Bazett and Friderici formulae. Any perioperative arrhythmias were recorded. Complete data were available for 62 patients. Volatile anesthesia was associated with significant prolongation of the QTc interval. Administration of droperidol after cardiopulmonary bypass was associated with further significant QTc prolongation. All QTc changes were transient and the postoperative QTc, while still prolonged relative to baseline, was significantly shorter than the QTc immediately postdroperidol. No episodes of Torsades de Pointes (TdP) or ventricular arrhythmias were observed. The administration of a neuroleptic dose of droperidol during volatile anesthesia in patients undergoing single ventricle palliation was associated with a significant prolongation of QTc, which was transient and did not result in TdP or other ventricular arrhythmias in our study population.

American Academy of Emergency Medicine Position Statement: Safety of Droperidol Use in the Emergency Department.

BACKGROUND: Droperidol (Inapsine®, Glaxosmithkline, Brent, UK) is a butyrophenone used in emergency medicine practice for a variety of uses. QT prolongation is a well-known adverse effect of this class of medications. Of importance to note, QT prolongation is noted with multiple medication classes, and droperidol increases QT interval in a dose-dependent fashion among susceptible individuals. The primary goal of this literature search was to determine the reported safety issues of droperidol in emergency department management of patients. METHODS: A MEDLINE literature search was conducted from January 1995 to January 2014 and limited to human studies written in English for articles with keywords of droperidol/Inapsine. Guideline statements and nonsystematic reviews were excluded. Studies identified then underwent a structured review from which results could be evaluated. RESULTS: There were 542 papers on droperidol screened, and 35 appropriate articles were rigorously reviewed in detail and recommendations given. CONCLUSION: Droperidol is an effective and safe medication in the treatment of nausea, headache, and agitation. The literature search did not support mandating an electrocardiogram or telemetry monitoring for doses < 2.5 mg given either intramuscularly or intravenously. Intramuscular doses of up to 10 mg of droperidol seem to be as safe and as effective as other medications used for sedation of agitated patients.

High dose droperidol and QT prolongation: analysis of continuous 12-lead recordings.

AIMS: To investigate the QT interval after high dose droperidol using continuous 12-lead Holter recordings. METHODS: This was a prospective study of patients given droperidol with a continuous Holter recording. Patients were recruited from the DORM II study which included patients with aggression presenting to the emergency department. Patients initially received 10 mg droperidol as part of a standardized sedation protocol. An additional 10 mg dose was given after 15 min if required and further doses at the clinical toxicologist's discretion. Continuous 12-lead Holter recordings were obtained for 2-24 h utilizing high resolution digital recordings with automated QT interval measurement. Electrocardiograms were extracted hourly from Holter recordings. The QT interval was plotted against heart rate (HR) on the QT nomogram to determine if it was abnormal. QTc F (Fridericia's HR correction) was calculated and >500 ms was defined as abnormal. RESULTS: Forty-six patients had Holter recordings after 10-40 mg droperidol and 316 QT-HR pairs were included. There were 32 abnormal QT measurements in four patients, three given 10 mg and one 20 mg. In three of the four patients QTc F >500 ms but only in one taking methadone was the timing of QTc F >500 ms consistent with droperidol dosing. Of the three other patients, one took amphetamines, one still had QT prolongation 24 h after droperidol and one took a lamotrigine overdose. No patient given >30 mg had a prolonged QT. There were no arrhythmias. CONCLUSION: QT prolongation was observed with high dose droperidol. However, there was little evidence supporting droperidol being the cause and QT prolongation was more likely due to pre-existing conditions or other drugs.

Droperidol for treatment of nausea and vomiting in palliative care patients.

BACKGROUND: This is an updated version of the original Cochrane review published in Issue 10, 2010, on droperidol for the treatment of nausea and vomiting in palliative care patients. Nausea and vomiting are common symptoms in patients with terminal illness and can be very unpleasant and distressing. There are several different types of antiemetic treatments that can be used to control these symptoms. Droperidol is an antipsychotic drug and has been used and studied as an antiemetic in the management of postoperative and chemotherapy nausea and vomiting. OBJECTIVES: To evaluate the efficacy and adverse events (both minor and serious) associated with the use of droperidol for the treatment of nausea and vomiting in palliative care patients. SEARCH METHODS: We searched electronic databases including CENTRAL, MEDLINE (1950-), EMBASE (1980-), CINAHL (1981-) and AMED (1985-), using relevant search terms and synonyms. The basic search strategy was ("droperidol" OR "butyrophenone") AND ("nausea" OR "vomiting"), modified for each database. We updated the search on 2 December 2009. We performed updated searches of MEDLINE, EMBASE, CENTRAL and AMED 2009 to 2013 on 19 November 2013 and of CINAHL on 20 November 2013. We also searched trial registers (metaRegister of controlled trials (www.controlled-trials.com/mrct), clinicaltrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/)) on 22 November 2013, using the keyword "droperidol". SELECTION CRITERIA: Randomised controlled trials (RCTs) of droperidol for the treatment of nausea or vomiting, or both, in adults receiving palliative care or suffering from an incurable progressive medical condition. DATA COLLECTION AND ANALYSIS: We judged the potential relevance of studies based on their titles and abstracts, and obtained studies that we anticipated might meet the inclusion criteria. Two review authors independently reviewed the abstracts for the initial review and four review authors reviewed the abstracts for the update to assess suitability for inclusion. We discussed discrepancies to achieve consensus. MAIN RESULTS: The 2010 search strategy identified 1664 abstracts (and 827 duplicates) of which we obtained 23 studies in full as potentially meeting the inclusion criteria. On review of the full papers, we identified no studies that met the inclusion criteria.The updated searches carried out in November 2013 identified 304 abstracts (261 excluding duplicates) of which we obtained 18 references in full as potentially meeting the inclusion criteria. On review of the full papers, we identified no studies that met the inclusion criteria, therefore there were no included studies in this review.We found no registered trials of droperidol for the management of nausea or vomiting in palliative care. AUTHORS' CONCLUSIONS: Since first publication of this review, no new studies were found. There is insufficient evidence to advise on the use of droperidol for the management of nausea and vomiting in palliative care. Studies of antiemetics in palliative care settings are needed to identify which agents are most effective, with minimum side effects.

Comparison of droperidol and haloperidol for use by paramedics: assessment of safety and effectiveness.

BACKGROUND: Since the 2001 "black box" warning on droperidol, its use in the prehospital setting has decreased substantially in favor of haloperidol. There are no studies comparing the prehospital use of either drug. The goal of this study was to compare QTc prolongation, adverse events, and effectiveness of droperidol and haloperidol among a cohort of agitated patients in the prehospital setting. METHODS: In this institutional review board-approved before and after study, we collected data on 532 patients receiving haloperidol (n = 314) or droperidol (n = 218) between 2007 and 2010. We reviewed emergency department (ED) electrocardiograms when available (haloperidol, n = 78, 25%; droperidol, n = 178, 76%) for QTc length (in milliseconds), medical records for clinically relevant adverse events (defined a priori as systolic blood pressure (SBP) <90 mmHg, seizure, administration of anti-dysrhythmic medications, cardioversion or defibrillation, bag-valve-mask ventilation, intubation, cardiopulmonary arrest, and prehospital or in-hospital death). We also compared effectiveness of the medications, using administration of additional sedating medications within 30 minutes of ED arrival as a proxy for effectiveness. RESULTS: The mean haloperidol dose was 7.9 mg (median 10 mg, range 4-20 mg). The mean droperidol dose was 2.9 mg (median 2.5 mg, range 1.25-10 mg.) Haloperidol was given i.m. in 289 cases (92%), and droperidol was given i.m. in 132 cases (61%); in all other cases, the medication was given i.v.. There was no statistically significant difference in median QTc after medication administration (haloperidol 447 ms, 95% CI: 440-454 ms; droperidol 454 ms, 95% CI: 450-457). There were no statistically significant differences in adverse events in the droperidol group as compared to the haloperidol group. One patient in the droperidol group with a history of congenital heart disease suffered a cardiopulmonary arrest and was resuscitated with neurologically intact survival. There was no significant difference in the use of additional sedating medications within 30 minutes of ED arrival after receiving droperidol (2.9%, 95% CI: -2.5-8.4%). CONCLUSIONS: In this cohort of agitated patients treated with haloperidol or droperidol in the prehospital setting, there was no significant difference found in QTc prolongation, adverse events, or need for repeat sedation between haloperidol and droperidol.

Coma After Droperidol Administration: A Case Report.

In Switzerland, approximately 32,000 patients are hospitalized annually due to adverse drug reactions (ADRs), representing 2.3% of all hospitalizations. During the perioperative period, the administration of a variety of drugs from different classes over a relatively short period of time increases the risk of ADR. Here, we describe the case of a 32-year-old woman who was administered droperidol to treat nausea in the recovery room after a myomectomy and who subsequently became comatose. Correctable metabolic, respiratory, and cerebrovascular disorders were ruled out. Six hours after the event, she was extubated without residual effects. We discuss potential ADR for droperidol.

Does low-dose droperidol increase the risk of polymorphic ventricular tachycardia or death in the surgical patient?

BACKGROUND: The Food and Drug Administration issued a black box warning regarding the use of droperidol and the potential for torsade de pointes. METHODS: The primary objective of this retrospective study was to determine if low-dose (0.625 mg) droperidol administration was associated with episodes of torsade de pointes in the general surgical population during the 3-yr period following the reinstitution of droperidol to our institutional formulary. RESULTS: The authors identified 20,122 surgical patients who received 35,536 doses of droperidol. These patients were cross-matched with an electrocardiogram database and an adverse outcome database. The charts of 858 patients were reviewed, including patients with documentation of prolonged QTc (>440 ms) from March 2007 to February 2011, polymorphic ventricular tachycardia (VT) within 48 h of receiving droperidol, or death within 7 days of receiving droperidol. Twelve surgical patients had VT (n = 4) or death (n = 8) documented within 48 h of droperidol administration. No patients developed polymorphic VT or death due to droperidol administration (n = 0). The eight patients that died were on palliative care. The four patients with documented VT had previous cardiac conditions: two had pre-existing implantable cardiac defibrillators, three had episodes of VT before receiving droperidol, and another had pre-existing hypertrophic obstructive cardiomyopathy. The authors found 523 patients with a documented QTc >440 ms before receiving droperidol. No patients developed VT or death as a direct result of droperidol administration. CONCLUSIONS: Our evidence suggests that low-dose droperidol does not increase the incidence of polymorphic VT or death when used to treat postoperative nausea and vomiting in the surgical population.

A prospective study of high dose sedation for rapid tranquilisation of acute behavioural disturbance in an acute mental health unit.

BACKGROUND: Acute behavioural disturbance (ABD) is a common problem in psychiatry and both physical restraint and involuntary parenteral sedation are often required to control patients. Although guidelines are available, clinical practice is often guided by experience and there is little agreement on which drugs should be first-line treatment for rapid tranquilisation. This study aimed to investigate sedation for ABD in an acute mental healthcare unit, including the effectiveness and safety of high dose sedation. METHODS: A prospective study of parenteral sedation for ABD in mental health patients was conducted from July 2010 to June 2011. Drug administration (type, dose, additional doses), time to sedation, vital signs and adverse effects were recorded. High dose parenteral sedation was defined as greater than the equivalent of 10 mg midazolam, droperidol or haloperidol (alone or in combination), compared to patients receiving 10 mg or less (normal dose). Effective sedation was defined as a fall in the sedation assessment tool score by two or a score of zero or less. Outcomes included frequency of adverse drug effects, time to sedation/tranquilisation and use of additional sedation. RESULTS: Parenteral sedation was given in 171 cases. A single drug was given in 96 (56%), including droperidol (74), midazolam (19) and haloperidol (3). Effective sedation occurred in 157 patients (92%), and the median time to sedation was 20 min (Range: 5 to 100 min). The median time to sedation for 93 patients receiving high dose sedation was 20 min (5-90 min) compared to 20 min (5-100 min; p = 0.92) for 78 patients receiving normal dose sedation. Adverse effects occurred in 16 patients (9%); hypotension (14), oxygen desaturation (1), hypotension and oxygen desaturation (1). There were more adverse effects in the high dose sedation group compared to the normal dose group [11/93 (12%) vs. 5/78 (6%); p = 0.3]. Additional sedation was given in 9 of 171 patients (5%), seven in the high dose and two in the normal dose groups. CONCLUSIONS: Large initial doses of sedative drugs were used for ABD in just over half of cases and additional sedation was uncommon. High dose sedation did not result in more rapid or effective sedation but was associated with more adverse effects.

Parenteral sedation of elderly patients with acute behavioral disturbance in the ED.

PURPOSES: This study aimed to investigate sedation of elderly patients with acute behavioral disturbance (ABD) in the emergency department (ED), specifically the safety and effectiveness of droperidol. BASIC PROCEDURES: This was a prospective study of elderly patients (>65 years) with ABD requiring parenteral sedation and physical restraint in the ED. Patients were treated with a standardized sedation protocol that included droperidol. Drug administration, time to sedation, additional sedation, and adverse effects were recorded. Effective sedation was defined as a drop in the sedation assessment tool score by 2 or a score of zero or less. MAIN FINDINGS: There were 49 patients with median age of 81 years (range, 65-93 years); 33 were males. Thirty patients were given 10 mg droperidol, 15 were given 5 mg droperidol, 2 were given 2.5 mg, and 2 were given midazolam. Median time to sedation for patients receiving 10 mg droperidol was 30 minutes (interquartile range, 18-40 minutes), compared with 21 minutes (interquartile range, 10-55 minutes; P = .55) for patients receiving 5 mg droperidol. Three patients were not sedated within 120 minutes. Eighteen patients required additional sedation-10 of 30 (33%; 95% confidence interval, 18%-53%) given droperidol 10 mg compared with 7 of 15 (47%; 95% confidence interval, 22%-73%) given 5 mg. Fourteen patients required resedation. Adverse effects occurred in 5 patients (hypotension [2], oversedation [2], hypotension/oversedation [1])-2 of 30 given 10 mg droperidol and 3 of 19 not treated according to protocol. Midazolam was given initially or for additional sedation in 2 of 5 adverse effects. No patient had QT prolongation. PRINCIPAL CONCLUSIONS: Droperidol was effective for sedation in most elderly patients with ABD, and adverse effects were uncommon. An initial 5-mg dose appears prudent with the expectation that many will require another dose.