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British Journal of Clinical Pharmacology Dec 2016Intramuscular droperidol is used increasingly for sedation of aggressive and violent patients. This study aimed to characterise the pharmacokinetics of intramuscular...
BACKGROUND
Intramuscular droperidol is used increasingly for sedation of aggressive and violent patients. This study aimed to characterise the pharmacokinetics of intramuscular droperidol in these patients to determine how rapidly it is absorbed and the expected duration of measurable drug concentrations.
METHODS
We undertook a population pharmacokinetic analysis of a subgroup of patients from a clinical trial comparing droperidol and midazolam: 17 receiving 5 mg and 24 receiving 10 mg droperidol. Droperidol was measured using high-performance liquid chromatography. Pharmacokinetic modelling was performed under a nonlinear mixed effects modelling framework (NONMEM v7.2). The model was used to simulate concentration time profiles of three typical doses, 5 mg, 10 mg and 10 mg + 10 mg repeated at 15 min.
RESULTS
A two-compartment first-order input with first-order output model fitted the data best. The absorption rate constant was poorly characterised by the data and an estimate of the first order rate constant of absorption when fixed to 10 h provided a stable model and lowest objective function. This represents extremely rapid absorption with a half-life of 5 min. The final model had a clearance of 41.9 l h and volume of distribution of the central compartment of, 73.6 l. Median and interquartile range of initial (alpha) half-life was 0.32 h (0.26-0.37 h) and second (beta) half-life was 3.0 h (2.5-3.6 h). Simulations indicate that 10 mg alone provides an 80% probability of being above the lower limit of quantification (5 μg l ) for 7 h, 2 h longer than for 5 mg. Giving two 10 mg doses increased this duration to 10 h.
CONCLUSIONS
Intramuscular droperidol is rapidly absorbed with high therapeutic concentrations after 5 and 10 mg doses, and supports clinical data in which droperidol sedates rapidly for up to 6 h.
Topics: Absorption, Physiological; Adult; Antipsychotic Agents; Computer Simulation; Droperidol; Female; Half-Life; Humans; Injections, Intramuscular; Male; Models, Biological; Predictive Value of Tests; Psychomotor Agitation; Randomized Controlled Trials as Topic
PubMed: 27530285
DOI: 10.1111/bcp.13093 -
Hospital Medicine (London, England :... Jun 1999
Topics: Adult; Antipsychotic Agents; Droperidol; Female; Humans; Neuroleptic Malignant Syndrome
PubMed: 10492720
DOI: 10.12968/hosp.1999.60.6.1140 -
Anaesthesia Apr 1994
Topics: Adult; Analgesia, Patient-Controlled; Droperidol; Female; Humans; Ophthalmoplegia; Postoperative Complications
PubMed: 8179150
DOI: 10.1111/j.1365-2044.1994.tb14194.x -
The British Journal of Psychiatry : the... Mar 2015Agitation 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... (Comparative Study)
Comparative Study Randomized 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.
Topics: Adolescent; Adult; Aged; Aggression; Antipsychotic Agents; Conscious Sedation; Droperidol; Female; Haloperidol; Humans; Male; Middle Aged; Occupational Injuries; Psychomotor Agitation; Time Factors; Young Adult
PubMed: 25395689
DOI: 10.1192/bjp.bp.114.150227 -
The American Journal of Emergency... Feb 2022To assess the QTc interval variation after low-dose droperidol in a population of undifferentiated, stable, and non-agitated patients receiving droperidol in the... (Observational Study)
Observational Study
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.
Topics: Adjuvants, Anesthesia; Adult; Antiemetics; Dose-Response Relationship, Drug; Droperidol; Emergency Service, Hospital; Female; Humans; Long QT Syndrome; Male; Prospective Studies; Young Adult
PubMed: 34959024
DOI: 10.1016/j.ajem.2021.12.039 -
Southern Medical Journal Oct 1983Twenty-one patients with vertigo related to inner ear disease were treated with droperidol as their sole form of therapy. I report the results and discuss droperidol...
Twenty-one patients with vertigo related to inner ear disease were treated with droperidol as their sole form of therapy. I report the results and discuss droperidol therapy in detail with regard to its pharmacology, dosage techniques, and the necessary precautions.
Topics: Droperidol; Humans; Labyrinth Diseases; Vertigo
PubMed: 6623141
DOI: 10.1097/00007611-198310000-00019 -
American Journal of Obstetrics and... Jun 1996Hyperemesis gravidarum is a common pregnancy complication requiring hospitalization. Continuous droperidol infusion and bolus intravenous diphenhydramine were instituted...
OBJECTIVE
Hyperemesis gravidarum is a common pregnancy complication requiring hospitalization. Continuous droperidol infusion and bolus intravenous diphenhydramine were instituted as treatment. We compared the number and length of hospitalizations for hyperemesis gravidarum, readmissions for this diagnosis, and pregnancy outcome in patients receiving this treatment protocol with a historic group of patients receiving other forms of parenteral therapy for hyperemesis gravidarum.
STUDY DESIGN
All patients hospitalized with a diagnosis of hyperemesis gravidarum between January 1992 and January 1994 were offered the droperidol-diphenhydramine protocol. These patients were compared with patients admitted between January 1990 and January 1992 with a diagnosis of hyperemesis gravidarum but who were not treated with droperidol at any time or with diphenhydramine as primary therapy for the control of severe nausea and vomiting. Data regarding the number and length of hospitalizations and readmissions for hyperemesis gravidarum were compared, as were maternal and perinatal outcomes.
RESULTS
Patients treated with the droperidol-diphenhydramine protocol had significantly shorter hospitalizations (3.1 +/- 1.9 vs 3.8 +/- 2.4 days, p = 0.028), fewer days per pregnancy hospitalized for hyperemesis (3.5 +/- 2.3 days vs 4.8 +/- 4.3 days, p = 0.018), and fewer readmissions with this diagnosis (15.0% vs 31.5%, p = 0.015). There were no significant differences in maternal or perinatal outcomes.
CONCLUSION
Droperidol and diphenhydramine infusion is a beneficial, cost-effective therapy for the treatment of hyperemesis gravidarum.
Topics: Adult; Delivery, Obstetric; Diphenhydramine; Droperidol; Female; Gestational Age; Humans; Hyperemesis Gravidarum; Length of Stay; Pregnancy; Pregnancy Outcome; Time Factors
PubMed: 8678143
DOI: 10.1016/s0002-9378(96)70213-2 -
Journal of Clinical Anesthesia Dec 2002In December 2001, the United States Food and Drug Administration (FDA) added a "black box" warning to the labeling for droperidol stating that all doses, even those...
In December 2001, the United States Food and Drug Administration (FDA) added a "black box" warning to the labeling for droperidol stating that all doses, even those typically used for postoperative nausea and vomiting, were potentially associated with malignant ventricular dysrhythmias, including torsade de pointes. The 19 cases in which droperidol doses less than 10 mg were allegedly associated with such dysrhythmias are reviewed in detail. Confounding issues present in a majority of the cases make it difficult to incriminate droperidol as the likely cause of the reported adverse events.
Topics: Adult; Aged; Antiemetics; Dose-Response Relationship, Drug; Droperidol; Drug Interactions; Drug Labeling; Female; Humans; Male; Middle Aged; Postoperative Nausea and Vomiting; Respiratory Mechanics; United States; United States Food and Drug Administration
PubMed: 12565120
DOI: 10.1016/s0952-8180(02)00445-2 -
Annals of Emergency Medicine Sep 2015
Topics: Conscious Sedation; Dangerous Behavior; Droperidol; Emergency Service, Hospital; Female; Humans; Hypnotics and Sedatives; Male
PubMed: 26116221
DOI: 10.1016/j.annemergmed.2015.05.030 -
Anesthesia and Analgesia Jun 1997
Topics: Antiemetics; Droperidol; Drug Synergism; Drug Therapy, Combination; Humans; Ondansetron
PubMed: 9174330
DOI: 10.1097/00000539-199706000-00043