Abstract:
BACKGROUND:Due to possible serious adverse drug reactions (ADRs), the use of metamizole for postoperative pain therapy in children is a subject of debate. Safety studies with large sample sizes have not been published as yet. OBJECTIVE:The aim of this study was to evaluate the use of metamizole in children aged up to 6 years undergoing surgery with a particular focus on serious ADRs such as haemodynamic, anaphylactic or respiratory reactions and agranulocytosis. DESIGN:A multicentre, prospective, noninterventional, observational postauthorisation safety study (PASS). SETTING:The study was conducted in six different paediatric centres from September 2013 to September 2014. PATIENTS:One thousand one hundred and seventy-seven children aged up to six years (American Society of Anesthesiologists' physical status class I to III) receiving a single dose of metamizole for postoperative pain therapy were enrolled. MAIN OUTCOME MEASURES:Patient demographics, main and secondary diagnoses, surgical procedures performed, metamizole dose, haemodynamic data, use of other analgesics and regional blocks, results of pain measurement (Children and Infants Postoperative Pain Scale, ChIPPS) and ADR incidence were documented using a standardised case report form. RESULTS:Of the 1177 children observed at six paediatric centres, 1145 were included for analysis [age 35.8 ± 18.1 (0.1 to 72) months]. The mean metamizole dose was 17.3 ± 2.9 (8.3 to 29.4) mg kg(-1). Mean arterial pressure (MAP) remained stable during metamizole infusion [baseline 55.7 ± 1.3 (25 to 98) and after infusion 56.6 ± 11.3 (25 to 99) mmHg; P < 0.01]. Pruritus, swelling and exanthema were observed in one patient each (total 0.3%). No respiratory adverse events directly related to the metamizole administration and no clinical signs of agranulocytosis were reported. All data are mean ± SD (range). CONCLUSION:Single intravenous doses of metamizole used for the prevention or treatment of postoperative pain were well tolerated in more than 1000 children aged up to 6 years. The probability of serious ADRs (haemodynamic, anaphylactic or respiratory reactions) is lower than 0.3%. The sample size and follow-up was not sufficient to detect episodes of agranulocytosis.
journal_name
Eur J Anaesthesioljournal_title
European journal of anaesthesiologyauthors
Fieler M,Eich C,Becke K,Badelt G,Leimkühler K,Messroghli L,Boethig D,Sümpelmann Rdoi
10.1097/EJA.0000000000000272subject
Has Abstractpub_date
2015-12-01 00:00:00pages
839-43issue
12eissn
0265-0215issn
1365-2346journal_volume
32pub_type
杂志文章,多中心研究abstract:BACKGROUND AND OBJECTIVE:Several reports concerning the haemodynamic changes during gynaecologic laparoscopy have been published so far, and the effects of head-down tilt and pneumoperitoneum have not been clearly separated. However, its main effect seems to be an increase in systemic vascular resistance. We investigat...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0b013e32832cb3c9
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:It has been hypothesized that combinations of analgesics with different mechanisms of action may reduce or even prevent postoperative pain. We, therefore, investigated the analgesic effect of gabapentin, dexamethasone and low-dose ketamine in combination with paracetamol and ketorolac as compar...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章,随机对照试验
doi:10.1097/EJA.0b013e328331c71d
更新日期:2010-04-01 00:00:00
abstract::A 36-year-old female presented with seizures and transient dysphasia in her 31 week of pregnancy. Neuroradiological investigations revealed a large falx meningioma. A decision was taken to deliver the infant and excise the tumor before term because of the risk of an increase in the size of the tumour and the risk of s...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1046/j.1365-2346.1998.00225.x
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Statins are prescribed for patients with hypercholesterolemia. Atorvastatin is metabolized by cytochrome P4503A4 and inhibits P4503A4 activity in vitro. Alfentanil is a potent opioid used in clinical anaesthetic practice and is also metabolized by P4503A4. This study tested the hypothesis that ...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章
doi:10.1017/s0265021503001078
更新日期:2003-08-01 00:00:00
abstract::The effects of 5% and 8% glucose in 0.5% tetracaine or bupivacaine on the anaesthetic spread were investigated in 80 urological patients requiring spinal anaesthesia for trans-urethral resection of the prostate. The local anaesthetic solutions were randomly administered, the patients being divided into four groups of ...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1989-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The intubating laryngeal mask is designed to act as a ventilatory device and as an aid to blind tracheal intubation in adults. The aim of this study was to evaluate the efficacy of the intubating laryngeal mask for ventilation of the lungs and tracheal intubation in children using video-endosco...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1046/j.1365-2346.2001.00909.x
更新日期:2001-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The effects of bicarbonated Ringer's solution were evaluated and compared with those of acetated Ringer's, lactated Ringer's and Ringer's solutions in partially hepatectomized rabbits. METHOD:Animals were randomly divided into six groups (n = 6 in each group): a sham-operated group, an operate...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1017/s0265021505001043
更新日期:2005-08-01 00:00:00
abstract::Malignant hyperthermia is an autosomal-dominant inherited disorder of the skeletal muscle cell characterized by a hypermetabolic response to all commonly used inhalational anaesthetics and depolarizing muscle relaxants. The clinical syndrome includes muscle rigidity, hypercapnia, tachycardia and myoglobinuria as resul...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2346.2001.00888.x
更新日期:2001-10-01 00:00:00
abstract::The thrombogenicity of polyethylene, silicone and polyurethane central venous catheters was compared in a prospective clinical, phlebographic and post-mortem study in 52 patients. The incidence of central venous thrombosis was high with polyethylene catheters (70%), but much lower with silicone (20%) and with polyuret...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1984-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Most therapeutic options for postoperative delirium are only symptom oriented; therefore, the best approach remains prevention. The aim of this study was to identify predisposing and precipitating factors for early postoperative delirium. METHODS:A total of 1002 patients were screened for deli...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0b013e3283335cee
更新日期:2010-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The study compared the analgesic efficacy and safety of two preoperatively administered cyclo-oxygenase-2 inhibitors, celecoxib and rofecoxib. METHODS:Ninety adult patients undergoing thyroid surgery were divided into three groups (each n = 30). They were given a single oral dose of placebo, c...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1017/s0265021503000796
更新日期:2003-06-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Left ventricular non-compaction (LVNC) is a relatively uncommon cardiomyopathy. The implications of the presence of LVNC in the perioperative period are unknown. The objective of this study was to determine the impact of LVNC on post-operative complications. METHODS:This retrospective cohort s...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0b013e328341014c
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:We investigated whether glibenclamide (glyburide) affects myocardial metabolism and hydroxyl radical formation in the rat heart-lung preparation with or without inhalation anaesthetics. METHODS:Thirty-seven male Wistar rats were allocated to four groups: (a) control group (C), received vehicle...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1046/j.1365-2346.2001.00927.x
更新日期:2001-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Acute renal failure is a serious complication of cardiac surgery. We studied the long-term survival and quality of life of patients requiring renal replacement therapy after cardiac surgery, since they represent a heavy burden on hospital resources and their outcome has never been adequately ev...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章
doi:10.1017/S0265021505001705
更新日期:2006-01-01 00:00:00
abstract::Ninety-eight patients scheduled for elbow, forearm, wrist or hand surgery were allocated randomly to one of two different techniques of brachial plexus block, both using the axillary approach. The blocks were all performed at the level of the insertion of the lateral margin of the pectoralis major muscle on the humeru...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1995-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Primary brain tumours may be associated with coagulation disorders, which can pose intraoperative and postoperative management difficulties. Thromboelastography is a useful technique for evaluating coagulability. In this study, we evaluated the perioperative coagulation profile using both stand...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0b013e32831c8b5f
更新日期:2009-04-01 00:00:00
abstract::Competency frameworks are based on what are considered to be the general essential qualities of a doctor. Competencies, being behavioural descriptors, need a strong link to clinical practice to allow trainers to observe and then use them in assessing trainees' performance. The emerging concept of entrustable professio...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章,评审
doi:10.1097/EJA.0000000000000109
更新日期:2015-02-01 00:00:00
abstract::The initial disposition of propofol was reported to change when the administration was preceded by fentanyl. The pharmacokinetic profile of the induction dose of propofol (2 mg kg-1 body weight) was studied in 20 ASA I patients randomly allocated to receive fentanyl 1.5 microgram kg-1 (n = 12) or not (n = 8). Anaesthe...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1994-03-01 00:00:00
abstract::The effect of tramadol on laryngeal reflex activity was assessed in a double-blind cross-over study in six volunteers receiving single oral doses of either codeine 50 mg, tramadol 50 mg or tramadol 100 mg. Laryngeal reactivity was measured by the response to the inhalation of dilute ammonia vapour. The minimum ammonia...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章
doi:
更新日期:1992-03-01 00:00:00
abstract::Anaesthetic agents for day-case surgery ideally should have a short duration of action. This study was designed to compare the efficacy and safety of mivacurium and vecuronium for healthy adults undergoing dental day-case surgery. Thirty fit healthy adult patients (ASA I or II) randomly received either mivacurium 0.15...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2346.1994.00207.x
更新日期:1997-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Administration of calcium safely and effectively reverses many of the electrophysiological actions of hyperkalaemia, but it has not been studied for pretreatment. Based on cellular studies, magnesium also has been suggested to prevent the effects of potassium on the heart. As their mechanisms o...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1017/s0265021503000978
更新日期:2003-08-01 00:00:00
abstract::There is an increasing body of evidence that volatile anaesthetics protect myocardium against ischaemic insult by a mechanism termed 'anaesthetic preconditioning'. Anaesthetic preconditioning and ischaemic preconditioning share several common mechanisms of action. Since ischaemic preconditioning has been demonstrated ...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章,评审
doi:10.1017/S0265021507000531
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Intraoperative Doppler ultrasound can be used to measure cardiac output by transoesophageal echocardiography. Recently, its reliability, when compared to the thermodilution technique, has been questioned. The purpose of this study was to compare intraoperative changes in cardiac output measured...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1017/S0265021507001354
更新日期:2008-02-01 00:00:00
abstract::Patients with bilateral corneal blindness in whom corneal transplantation has either been unsuccessful or inappropriate may be considered for osteo-odonto-keratoprosthesis surgery. During a two-stage procedure the surface of the cornea is removed and covered with a graft of buccal mucosa. An optical cylinder, supporte...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2346.2000.00698.x
更新日期:2000-06-01 00:00:00
abstract:BACKGROUND:The dorsalis pedis artery (DPA) is a good alternative to the radial artery (RA) for invasive blood pressure monitoring when the upper limb is burned or injured, or if the RA is not available. Understanding the pattern of pressure difference between DPA and the commonly used RA during inhalational anaesthesia...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0000000000000295
更新日期:2016-02-01 00:00:00
abstract:BACKGROUND:Acute neuropathic pain can occur in the postoperative period but any link with persistent post-surgical neuropathic pain remains unclear. OBJECTIVES:The objectives of this study were to prospectively describe the incidence of acute post-surgical neuropathic pain in a large population using the DN4 (clinicia...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1097/EJA.0000000000000634
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND:Pulse pressure variation (PPV) is a well known dynamic preload indicator of fluid responsiveness. However, its usefulness in open-chest conditions remains controversial. OBJECTIVE:We evaluated whether augmented PPV during a Valsalva manoeuvre can predict fluid responsiveness after sternotomy. DESIGN:A pros...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章
doi:10.1097/EJA.0000000000000613
更新日期:2017-05-01 00:00:00
abstract::Sixty patients were randomly assigned to two equal groups. Group I received epidural morphine 1 mg after surgery and used a patient-controlled analgesia device programmed to deliver morphine 0. 2 mg h-1, 0.2 mg per bolus. Group II received an epidural loading dose of morphine 1 mg plus ketamine 5 mg and used a patient...
journal_title:European journal of anaesthesiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2346.1999.00592.x
更新日期:1999-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Because gastric mucosal PCO2 must be referenced to arterial values via a gastric-to-arterial PCO2 gap (Pg-aCO2), the gastric-to-end-tidal PCO2 difference (Pg-ETCO2) may be proposed as a surrogate method to monitor Pg-aCO2. However, the influence of arterial-to-end-tidal PCO2 (Pa-ETCO2) on its v...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1017/s0265021503000279
更新日期:2003-02-01 00:00:00
abstract:BACKGROUND:Myocardial injury after noncardiac surgery (MINS) is a major contributor to peri-operative morbidity and mortality with a reported incidence of about 8%. Tachycardia increases myocardial oxygen demand, and decreases oxygen supply, and is therefore a potential cause of MINS. OBJECTIVE:We tested the hypothesi...
journal_title:European journal of anaesthesiology
pub_type: 杂志文章
doi:10.1097/EJA.0000000000000925
更新日期:2019-02-01 00:00:00