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JAMA Oct 2021Death rattle, defined as noisy breathing caused by the presence of mucus in the respiratory tract, is relatively common among dying patients. Although clinical... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Death rattle, defined as noisy breathing caused by the presence of mucus in the respiratory tract, is relatively common among dying patients. Although clinical guidelines recommend anticholinergic drugs to reduce the death rattle after nonpharmacological measures fail, evidence regarding their efficacy is lacking. Given that anticholinergics only decrease mucus production, it is unknown whether prophylactic application may be more appropriate.
OBJECTIVE
To determine whether administration of prophylactic scopolamine butylbromide reduces the death rattle.
DESIGN, SETTING, AND PARTICIPANTS
A multicenter, randomized, double-blind, placebo-controlled trial was performed in 6 hospices in the Netherlands. Patients with a life expectancy of 3 or more days who were admitted to the participating hospices were asked to give advance informed consent from April 10, 2017, through December 31, 2019. When the dying phase was recognized, patients fulfilling the eligibility criteria were randomized. Of the 229 patients who provided advance informed consent, 162 were ultimately randomized. The date of final follow-up was January 31, 2020.
INTERVENTIONS
Administration of subcutaneous scopolamine butylbromide, 20 mg four times a day (n = 79), or placebo (n = 78).
MAIN OUTCOMES AND MEASURES
The primary outcome was the occurrence of a grade 2 or higher death rattle as defined by Back (range, 0-3; 0, no rattle; 3, rattle audible standing in the door opening) measured at 2 consecutive time points with a 4-hour interval. Secondary outcomes included the time between recognizing the dying phase and the onset of a death rattle and anticholinergic adverse events.
RESULTS
Among 162 patients who were randomized, 157 patients (97%; median age, 76 years [IQR, 66-84 years]; 56% women) were included in the primary analyses. A death rattle occurred in 10 patients (13%) in the scopolamine group compared with 21 patients (27%) in the placebo group (difference, 14%; 95% CI, 2%-27%, P = .02). Regarding secondary outcomes, an analysis of the time to death rattle yielded a subdistribution hazard ratio (HR) of 0.44 (95% CI, 0.20-0.92; P = .03; cumulative incidence at 48 hours: 8% in the scopolamine group vs 17% in the placebo group). In the scopolamine vs placebo groups, restlessness occurred in 22 of 79 patients (28%) vs 18 of 78 (23%), dry mouth in 8 of 79 (10%) vs 12 of 78 (15%), and urinary retention in 6 of 26 (23%) vs 3 of 18 (17%), respectively.
CONCLUSIONS AND RELEVANCE
Among patients near the end of life, prophylactic subcutaneous scopolamine butylbromide, compared with placebo, significantly reduced the occurrence of the death rattle.
TRIAL REGISTRATION
trialregister.nl Identifier: NTR6264.
Topics: Aged; Aged, 80 and over; Butylscopolammonium Bromide; Cholinergic Antagonists; Confidence Intervals; Death; Double-Blind Method; Drug Administration Schedule; Female; Hospice Care; Humans; Incidence; Informed Consent; Injections, Subcutaneous; Life Expectancy; Male; Middle Aged; Netherlands; Placebos; Proportional Hazards Models; Respiratory Sounds; Treatment Outcome
PubMed: 34609452
DOI: 10.1001/jama.2021.14785 -
JA Clinical Reports Apr 2020There have been only few reports on butylscopolamine-induced anaphylaxis despite its global usage as an anticholinergic agent for approximately 70 years. We present a...
BACKGROUND
There have been only few reports on butylscopolamine-induced anaphylaxis despite its global usage as an anticholinergic agent for approximately 70 years. We present a case of anaphylaxis caused by butylscopolamine.
CASE PRESENTATION
A 63-year-old woman underwent gastrointestinal endoscopic examination. She developed facial cyanosis and hypoxia after intravenous administration of butylscopolamine 10 mg, and her blood pressure was unmeasurable. Her hemodynamic condition recovered after a total of 0.6 mg adrenaline and bolus administration of 100 mg hydrocortisone. One hour after the onset of hypotension, both plasma histamine and serum tryptase were remarkably elevated to 271.7 nmol/L and 174 μg/L, respectively. Skin tests performed 47 days after anaphylaxis showed a positive result only for butylscopolamine among the exposed agents, which was confirmed by basophil activation tests using CD203c and CD63 as markers.
CONCLUSION
Butylscopolamine has the potential to cause severe anaphylaxis; hence, identification of the causative agent is important to prevent recurrence of anaphylaxis.
PubMed: 32270308
DOI: 10.1186/s40981-020-00331-w -
PloS One 2022First-time mothers are prone to prolonged labor, defined as the crossing of partograph alert or action lines. Prolonged labor may occur among as many as one out of five...
Study protocol for the BUSCopan in LABor (BUSCLAB) study: A randomized placebo-controlled trial investigating the effect of butylscopolamine bromide to prevent prolonged labor.
BACKGROUND
First-time mothers are prone to prolonged labor, defined as the crossing of partograph alert or action lines. Prolonged labor may occur among as many as one out of five women, and is associated with a range of adverse birth outcomes. Oxytocin is the standard treatment for prolonged labor, but has a narrow therapeutic window, several adverse effects and limited efficacy. Despite poor evidence, labor wards often use antispasmodic agents to treat prolonged labor. The antispasmodic drug butylscopolamine bromide (Buscopan®) may shorten duration of labor, but studies on prevention of prolonged labor are lacking. In this randomized double-blind placebo-controlled clinical trial, we aim to evaluate the effect of butylscopolamine bromide on duration of labor in first-time mothers showing first signs of slow labor progress by crossing the World Health Organization partograph alert line.
METHODS AND ANALYSIS
The study is a single center study at Oslo University Hospital, Oslo, Norway. We will recruit 250 primiparous women with spontaneous labor start at term. Women are included in the first stage of labor if they show signs of slow labor progress, defined as the crossing of the partograph alert line with a cervical dilation between 3-9 cm. Participants are randomized 1:1 to either 20 mg intravenous butylscopolamine bromide or intravenous placebo (1 mL sodium chlorine 9 mg/mL). We considered a mean difference of 60 minutes in labor duration clinically relevant. The primary outcome is duration of labor from the provision of the investigational medicinal product to vaginal delivery. The secondary outcomes include change in labor pain, use of oxytocin augmentation, delivery mode, and maternal birth experience. The primary data for the statistical analysis will be the full analysis set and will occur on completion of the study as per the prespecified statistical analysis plan. The primary outcome will be analyzed using Weibull regression, and we will treat cesarean delivery as a censoring event.
Topics: Pregnancy; Female; Humans; Butylscopolammonium Bromide; Oxytocin; Bromides; Labor, Obstetric; Delivery, Obstetric; Randomized Controlled Trials as Topic
PubMed: 36327275
DOI: 10.1371/journal.pone.0276613 -
BMC Emergency Medicine Sep 2023BACKGROUND: Treatment of acute pain is an essential element of pre-hospital care for injured and critically ill patients. Clinical studies indicate the need for...
ABSTRAC
BACKGROUND: Treatment of acute pain is an essential element of pre-hospital care for injured and critically ill patients. Clinical studies indicate the need for improvement in the prehospital analgesia.
OBJECTIVE
The aim of this study is to assess the current situation in out of hospital pain management in Germany regarding the substances, indications, dosage and the delegation of the use of analgesics to emergency medical service (EMS) staff.
MATERIAL AND METHODS
A standardized survey of the medical directors of the emergency services (MDES) in Germany was carried out using an online questionnaire. The anonymous results were evaluated using the statistical software SPSS (Chi-squared test, Mann-Whitney-U test).
RESULTS
Seventy-seven MDES responsible for 989 rescue stations and 397 EMS- physician bases in 15 federal states took part in this survey. Morphine (98.7%), Fentanyl (85.7%), Piritramide (61%), Sufentanil (18.2%) and Nalbuphine (14,3%) are provided as opioid analgesics. The non-opioid analgesics (NOA) including Ketamine/Esketamine (98,7%), Metamizole (88.3%), Paracetamol (66,2%), Ibuprofen (24,7%) and COX-2-inhibitors (7,8%) are most commonly available. The antispasmodic Butylscopolamine is available (81,8%) to most rescue stations. Fentanyl is the most commonly provided opioid analgesic for treatment of a traumatic pain (70.1%) and back pain (46.8%), Morphine for visceral colic-like (33.8%) and non-colic pain (53.2%). In cases of acute coronary syndrome is Morphine (85.7%) the leading analgesic substance. Among the non-opioid analgesics is Ketamine/Esketamine (90.9%) most frequently provided to treat traumatic pain, Metamizole for visceral colic-like (70.1%) and non-colic (68.6%) as well as back pain (41.6%). Butylscopolamine is the second most frequently provided medication after Metamizole for "visceral colic-like pain" (55.8%). EMS staff (with or without a request for presence of the EMS physician on site) are permitted to use the following: Morphine (16.9%), Piritramide (13.0%) and Nalbuphine (10.4%), and of NOAs for (Es)Ketamine (74.1%), Paracetamol (53.3%) and Metamizole (35.1%). The dosages of the most important and commonly provided analgesic substances permitted to independent treatment by the paramedics are often below the recommended range for adults (RDE). The majority of medical directors (78.4%) of the emergency services consider the independent application of analgesics by paramedics sensible. The reason for the relatively rare authorization of opioids for use by paramedics is mainly due to legal (in)certainty (53.2%).
CONCLUSION
Effective analgesics are available for EMS staff in Germany, the approach to improvement lies in the area of application. For this purpose, the adaptations of the legal framework as well as the creation of a guideline for prehospital analgesia are useful.
Topics: Adult; Humans; Ketamine; Analgesics, Non-Narcotic; Dipyrone; Acetaminophen; Nalbuphine; Pirinitramide; Butylscopolammonium Bromide; Physician Executives; Analgesics; Analgesics, Opioid; Fentanyl; Germany; Acute Pain; Morphine Derivatives
PubMed: 37710177
DOI: 10.1186/s12873-023-00878-8 -
British Journal of Anaesthesia Dec 2013Catheter-related bladder discomfort (CRBD) secondary to intraoperative catheterization of urinary bladder is one of the most distressing symptoms during recovery from... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Catheter-related bladder discomfort (CRBD) secondary to intraoperative catheterization of urinary bladder is one of the most distressing symptoms during recovery from anaesthesia. Butylscopolamine, a peripheral antimuscarinic agent, is effective for relieving the pain, which is because of smooth muscle contraction. The aim of this study was to assess the efficacy and safety profiles of butylscopolamine in treating CRBD after urological surgeries.
METHODS
Adult male patients undergoing urological surgery requiring urinary bladder catheterization intraoperatively were enrolled. Induction and maintenance of anaesthesia were standardized. Patients were randomized into two groups after complaining of CRBD in the post-anaesthesia care unit. The control group (n=29) received normal saline and the butylscopolamine group (n=28) was administered butylscopolamine 20 mg i.v. The severity of CRBD, postoperative pain, and adverse effects were assessed at baseline, 20 min, 1, 2, and 6 h after administration of the study drug.
RESULTS
The severity of CRBD observed in the butylscopolamine group was significantly lower than that of the control group at 1, 2, and 6 h after administration of the study drug [59 (12), 50 (16), 40 (21) in the control group vs 41 (22), 32 (25), 23 (18) in the butylscopolamine group, P<0.01]. Rescue analgesics were required less in the butylscopolamine group than in the control group (P=0.001). Adverse events were comparable between the two groups.
CONCLUSION
Butylscopolamine 20 mg administered i.v. after complaining CRBD during recovery reduced both the severity of CRBD and the need for rescue analgesics without adverse effects in patients undergoing urologic surgeries.
Topics: Adult; Aged; Blood Pressure; Butylscopolammonium Bromide; Double-Blind Method; Dysuria; Heart Rate; Humans; Intraoperative Care; Male; Middle Aged; Muscarinic Antagonists; Pain Measurement; Pain, Postoperative; Postoperative Care; Prospective Studies; Treatment Outcome; Urinary Catheterization; Urologic Surgical Procedures, Male; Young Adult
PubMed: 23869107
DOI: 10.1093/bja/aet249 -
Journal of Pain and Symptom Management May 2022A need exists for studies investigating symptom relief at the end of life. Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of... (Review)
Review
A need exists for studies investigating symptom relief at the end of life. Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of medication, but they are difficult to perform at the end of life due to barriers such as the vulnerability of patients, and gatekeeping by healthcare professionals. We analyzed and reflected on recruitment, participation, and strategies used in an RCT at the end of life. The SILENCE study, performed in six inpatient hospice facilities, was a placebo-controlled trial to study the effect of ScopolamIne butyLbromidE giveN prophylactiCally for dEath rattle in dying patients. We addressed patients' vulnerability by using an advance consent procedure, and potential gatekeeping by extensive training of health care professionals and the appointment of hospice doctors as daily responsible researchers. In almost three years, 1097 patients were admitted of whom 626 were eligible at first assessment. Of these, 119 (19%) dropped out because of physical deterioration before they could be informed about the study (44) or sign informed consent (75). Twenty-five (4%) patients were not asked to participate. In 24 cases (4%), relatives advised against the patient participating. Overall, 229 patients (37%) gave informed consent to participate. The vulnerability of patients was the most important barrier in this medication study at the end of life. Gatekeeping by HCPs and relatives occurred in a small number of patients. The robust design and applied strategies to facilitate patient recruitment in this study resulted in a successful study with sufficient participants.
Topics: Butylscopolammonium Bromide; Death; Hospice Care; Hospitalization; Humans; Informed Consent; Multicenter Studies as Topic; Randomized Controlled Trials as Topic
PubMed: 34954069
DOI: 10.1016/j.jpainsymman.2021.12.018 -
World Journal of Gastroenterology Jun 2014To investigate the benefits of hyoscine butylbromide in polyp detection during colonoscopy by a meta-analysis of available randomized controlled trials (RCTs). (Meta-Analysis)
Meta-Analysis Review
AIM
To investigate the benefits of hyoscine butylbromide in polyp detection during colonoscopy by a meta-analysis of available randomized controlled trials (RCTs).
METHODS
Databases, including PubMed, EMBASE, the Cochrane Library, and the Science Citation Index up to September 2013, were searched. The primary outcome was polyp detection rate, and the secondary outcome was adenoma detection rate. The meta-analysis was performed using the free software Review Manager. Differences observed between the treated and the control groups were expressed as odds ratio (OR) with a 95% confidence interval (CI). A fixed-effects model was used to pool data when statistical heterogeneity was absent. If statistical heterogeneity was present (P < 0.05), a random-effects model was used.
RESULTS
The initial search identified nine articles. After screening, five RCTs with a total of 1998 patients were included in this meta-analysis. Of the five studies, all described a comparison of baseline patient characteristics and showed that there was no statistically significant difference between the two groups. Among the 1998 patients, 1006 received hyoscine butylbromide and 992 were allocated to the control group, and the polyp detection rate was reported. There were no significant differences between the treated and the control group (OR = 1.09, 95%CI: 0.91-1.31, P = 0.33). Four RCTs included 1882 patients, of whom 948 received hyoscine butylbromide, and the adenoma detection rate was reported. There were no significant differences between the treated and the control group (OR = 1.13, 95%CI: 0.92-1.38, P = 0.24).
CONCLUSION
The use of hyoscine butylbromide did not significantly improve the polyp detection rate during colonoscopy.
Topics: Adenoma; Butylscopolammonium Bromide; Chi-Square Distribution; Colonic Neoplasms; Colonic Polyps; Colonoscopy; Humans; Odds Ratio; Parasympatholytics; Predictive Value of Tests; Randomized Controlled Trials as Topic
PubMed: 24944499
DOI: 10.3748/wjg.v20.i22.7034 -
Journal of Pain and Symptom Management Feb 2007The use of symptomatic agents has greatly improved the medical treatment of advanced cancer patients with inoperable bowel obstruction. A systematic review of studies of... (Review)
Review
The use of symptomatic agents has greatly improved the medical treatment of advanced cancer patients with inoperable bowel obstruction. A systematic review of studies of the most popular drugs used in the medical management of inoperable malignant bowel obstruction was performed to assess the effectiveness of these treatments and provide some lines of evidence. Randomized trials that involved patients with a clinical diagnosis of intestinal obstruction due to advanced cancer treated with these drugs were reviewed. Five reports fulfilled inclusion criteria. Three studies compared octreotide (OC) and hyoscine butylbromide (HB), and two studies compared corticosteroids (CSs) and placebo. Globally, 52 patients received OC, 51 patients received HB, 37 patients received CSs, 15 patients received placebo, and 37 patients received both placebo and CSs. On the basis of these few data, the superiority of OC over HB in relieving gastrointestinal symptoms was evidenced in a total of 103 patients. The latter studies had samples more defined in terms of stage and inoperability, and had a shorter survival in comparison with studies of CSs (less than 61 days, most of them less than 20 days). Data on CSs are less convincing, due to the methodological weakness of existing studies. This review confirms the difficulties in conducting randomized controlled trials in this population.
Topics: Adrenal Cortex Hormones; Butylscopolammonium Bromide; Gastrointestinal Agents; Humans; Intestinal Obstruction; Muscarinic Antagonists; Neoplasms; Octreotide
PubMed: 17280927
DOI: 10.1016/j.jpainsymman.2006.06.014 -
International Journal of Legal Medicine Jul 2021Scopolamine is an alkaloid which acts as competitive antagonists to acetylcholine at central and peripheral muscarinic receptors. We report the case of a 41-year-old...
Scopolamine is an alkaloid which acts as competitive antagonists to acetylcholine at central and peripheral muscarinic receptors. We report the case of a 41-year-old male convict with a 27-year history of cannabis abuse who suddenly died in the bed of his cell after having smoked buscopan® tablets. Since both abuse of substances and recent physical assaults had been reported, we opted for a comprehensive approach (post-mortem computed tomography CT (PMCT), full forensic autopsy, and toxicology testing) to determine which was the cause of the death. Virtopsy found significant cerebral edema and lungs edema that were confirmed at the autopsy and at the histopathological examination. Scopolamine was detected in peripheral blood at the toxic concentration of 14 ng/mL in blood and at 263 ng/mL in urine, and scopolamine butyl bromide at 17 ng/mL in blood and 90 ng/mL in urine. Quetiapine, mirtazapine, lorazepam, diazepam, and metabolites and valproate were also detected (at therapeutic concentrations). Inmates, especially when they have a history of drug abuse, are at risk to use any substance they can find for recreational purposes. In prisons, active surveillance on the management and assumption of prescribed drugs could avoid fatal acute intoxication.
Topics: Adult; Autopsy; Butylscopolammonium Bromide; Edema; Fatal Outcome; Forensic Toxicology; Humans; Male; Prisoners; Scopolamine; Substance Abuse Detection
PubMed: 33890166
DOI: 10.1007/s00414-021-02583-2 -
Journal of Pain and Symptom Management Dec 2018Death rattle (DR) is a dramatic sign in the dying patient. Existing studies with anticholinergic agents are controversial, as this class of drugs has been commonly... (Comparative Study)
Comparative Study Randomized Controlled Trial
CONTEXT
Death rattle (DR) is a dramatic sign in the dying patient. Existing studies with anticholinergic agents are controversial, as this class of drugs has been commonly administered without considering the rationale of the mechanism of action. A meaningful use of these drugs may provide a better outcome.
OBJECTIVES
The aim of this study was to assess the efficacy of hyoscine butylbromide (HB), given prophylactically in comparison with HB administered once DR occurs.
METHODS
Dying patients having a score of ≥3 in the Richmond Agitation-Sedation Scale-palliative version were included in the study. HB (60 mg/day) was given when DR occurred (Group 1) or as pre-emptive treatment (Group 2). The onset of DR (death rattle free time) and intensity of DR were recorded at intervals until death.
RESULTS
Eighty-one and 51 patients were randomized to Group 1 and 2, respectively. Patients in Group 2 survived longer than those in Group 1 (P < 0.05). DR occurred in 49 (60.5%) and three patients (5.9%) in Group 1 and 2, respectively (P = 0.001). A significant difference in the number of patients reporting DR was found at intervals examined (30 minutes, one hour, and then every six hours until death [P = 0.001]). In Group 1 and 2, DR free time was 20.4 (20.5) and 27.3 hours (25.2), respectively (P = 0.001). In Group 1, the treatment was considered effective in 10 patients (20.4%) only, after a mean of 14.4 hours (SD 8.57).
CONCLUSION
The prophylactic use of HB is an efficient method to prevent DR, whereas the late administration produces a limited response, confirming data from traditional studies performed with anticholinergics. This could be considered a new paradigm to manage a difficult and dramatic sign, such as DR.
Topics: Aged; Butylscopolammonium Bromide; Death; Disease Management; Drug Administration Schedule; Female; Humans; Kaplan-Meier Estimate; Male; Neoplasms; Palliative Care; Parasympatholytics; Respiratory Sounds; Terminal Care; Treatment Outcome
PubMed: 30172864
DOI: 10.1016/j.jpainsymman.2018.08.018