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2.
PLoS One ; 13(6): e0199930, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29953514

RESUMO

BACKGROUND: Postoperative nausea and vomiting (PONV) is a common adverse effect of opioid-based intravenous patient-controlled analgesia (IV PCA). Nefopam has been considered as a good candidate for inclusion in multimodal analgesia because of its opioid sparing effect, but it can be emetic. This study aims to examine whether the use of nefopam combined with fentanyl in IV PCA was associated with the higher incidence of PONV in patients receiving prophylactic ramosetron after gynecological surgery. METHODS: Data from 296 patients who underwent gynecological surgery were retrospectively reviewed. The patients received IV PCA containing either fentanyl 1500 µg and ketorolac 90 mg (Group K) or fentanyl 1500 µg and nefopam 80 mg (Group N). All patients in both groups received 0.3 mg of ramosetron at the end of surgery. The primary outcome measure was the incidence of PONV during the 3-day postoperative period. RESULTS: No difference was observed in the incidence of PONV during the 3-day postoperative period between the two groups. However, the incidence of nausea on postoperative day 2 was significantly higher in Group N (10.3%) than in Group K (2.8%) (P = 0.016). Multivariable logistic regression analysis showed that the use of nefopam was not associated with a higher incidence of PONV (adjusted odds ratio, 1.616; 95% confidence interval, 0.952-2.743, P = 0.076). There were no differences in postoperative pain scores between the two groups. CONCLUSION: The combined use of nefopam with fentanyl in IV PCA was not associated with the higher incidence of PONV compared with the use of ketorolac and fentanyl combination in patients who received ramosetron as PONV prophylactic agent. However, prospective trials are required for a confirmative conclusion.


Assuntos
Analgesia Controlada pelo Paciente , Anestesia Obstétrica , Benzimidazóis/administração & dosagem , Procedimentos Cirúrgicos em Ginecologia , Nefopam/efeitos adversos , Náusea e Vômito Pós-Operatórios , Adulto , Analgesia Controlada pelo Paciente/efeitos adversos , Analgesia Controlada pelo Paciente/métodos , Anestesia Obstétrica/efeitos adversos , Anestesia Obstétrica/métodos , Feminino , Fentanila/administração & dosagem , Fentanila/efeitos adversos , Humanos , Incidência , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Náusea e Vômito Pós-Operatórios/induzido quimicamente , Náusea e Vômito Pós-Operatórios/epidemiologia , Náusea e Vômito Pós-Operatórios/prevenção & controle , Estudos Retrospectivos
4.
Int J Obstet Anesth ; 31: 84-90, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28347572

RESUMO

BACKGROUND: Nefopam is a centrally acting analgesic which has a theoretical risk of stopping lactation due to its anticholinergic and dopaminergic effects. The aim of this study was to evaluate the effect of nefopam on lactation and to investigate potential adverse effects on newborns. METHODS: Seventy-two women, scheduled to undergo a caesarean delivery under spinal anaesthesia and wanting to breastfeed, were randomised to one of two groups: nefopam (20mg, six hourly) or paracetamol (1g, six hourly). In both groups, postoperative analgesia was supplemented with ketoprofen (50mg, six hourly) in conjunction with intrathecal morphine 0.1mg. The primary outcome was onset of lactation, estimated by weighing the newborns before and after feeding; by maternal perception of breast fullness and based on serum prolactin concentration 48hours postpartum. Secondary outcomes were neonatal adverse effects evaluated by neurobehavioural score at 12, 24, 48, and 72hours after birth. Statistical analyses were performed using Chi-squared, Fisher exact and Student t tests as appropriate. P<0.05 was considered statistically significant. RESULTS: The difference in the weight of the newborn before and after each feed, maternal perception of breast fullness and serum prolactin did not significantly differ between groups. The volume of artificial milk given to newborns of mothers in the nefopam group on days two and three was significantly greater than for the paracetamol group. Neurobehavioural scores were comparable at each time point. CONCLUSION: Nefopam does not appear to delay the onset of lactation or present any clear risk to the newborn.


Assuntos
Analgésicos não Entorpecentes/efeitos adversos , Cesárea , Lactação/efeitos dos fármacos , Nefopam/efeitos adversos , Acetaminofen/efeitos adversos , Acetaminofen/uso terapêutico , Adulto , Analgésicos não Entorpecentes/uso terapêutico , Anestesia Obstétrica , Raquianestesia , Peso Corporal , Aleitamento Materno/psicologia , Feminino , Humanos , Comportamento do Lactente , Recém-Nascido , Nefopam/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Gravidez , Prolactina/sangue , Método Simples-Cego
5.
J Int Med Res ; 44(4): 844-54, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27358262

RESUMO

OBJECTIVES: A double-blind randomised study to evaluate the opioid sparing effect and safety of nefopam when administered via intravenous patient controlled analgesia (PCA) with fentanyl. METHODS: Patients planned for elective open laparotomy, were randomly assigned to receive into fentanyl 25 µg/ml (SF group) or nefopam 2.4 mg/ml plus fentanyl 25 µg/ml (NF group). Patients were assessed before surgery and for 24 h postoperatively. RESULTS: Total PCA fentanyl consumption was significantly lower in the NF group (n = 35) than the SF group (n = 36). Pain scores were significantly lower and patients' satisfaction with treatment significantly better in the NF group than the SF group. Dry mouth and dizziness were significantly more frequent in the NF group than the SF group. There were no other statistically significant between-group differences in the incidence of adverse events. CONCLUSIONS: Intravenous PCA using nefopam + fentanyl following laparotomy has an opioid sparing effect and is associated with a low incidence of some of the typical opioid related adverse events. TRIAL REGISTRY: Clinicaltrials.gov Registration No: NCT02596269.


Assuntos
Analgesia Controlada pelo Paciente , Analgésicos Opioides/farmacologia , Laparotomia , Nefopam/efeitos adversos , Nefopam/farmacologia , Método Duplo-Cego , Feminino , Fentanila/farmacologia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Laparotomia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Satisfação do Paciente
6.
BMC Anesthesiol ; 15: 87, 2015 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-26055978

RESUMO

BACKGROUND: Shivering is a frequent complication following surgery and anaesthesia. A large variety of studies have been reported that nefopam may be efficacious for the prevention and treatment of perioperative shivering. Regrettably, there is still no conclusion of the efficacy and safety of nefopam for the prevention of perioperative shivering. The aim of this analysis is to evaluate the efficacy of nefopam for the prevention of perioperative shivering in patients undergoing different types of anaesthesia compared with placebo group and other active interventions. METHODS: PubMed, EMBASE, Cochrane Central Register of Control Trials were systematically searched for potentially relevant trials. Trial quality and extracted data were evaluated by two authors independently. Dichotomous data on the absence of shivering was extracted and analysed by using relative risk (RR) with 95% confidence interval (CI). Continuous outcome was abstracted and analysed by using weighted mean difference (WMD) with 95% confidence interval (CI). Outcome data was analysed by using random effect model or fixed effect model in accordance with heterogeneity. RESULTS: Compared with placebo, prophylactic administration of nefopam significantly reduced the risk of perioperative shivering not only in the patients under general anaesthesia but also neuraxial anaesthesia (RR 0.08; 95% CI 0.05-0.13). As compared with clonidine, nefopam was more efficacious in the prevention of perioperative shivering (RR 0.34; 95% CI 0.17-0.70). Nefopam has no influence on the extubation time (WMD 0.92; 95% CI -0.15-1.99). CONCLUSION: Our analysis has demonstrated that nefopam is associated with the decrease of risk of perioperative shivering following anaesthesia without influencing the extubation time.


Assuntos
Complicações Intraoperatórias/prevenção & controle , Nefopam/uso terapêutico , Tremor por Sensação de Frio/efeitos dos fármacos , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos não Entorpecentes/uso terapêutico , Anestesia/efeitos adversos , Anestesia/métodos , Clonidina/uso terapêutico , Humanos , Nefopam/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Anesth Analg ; 119(1): 58-63, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24806137

RESUMO

BACKGROUND: Induction of therapeutic hypothermia is often complicated by shivering. Nefopam, a nonsedative benzoxazocine analgesic, reduces the shivering threshold (triggering core temperature) with minimal side effects. Consequently, nefopam is an attractive drug for inducing therapeutic hypothermia. However, nefopam alone is insufficient and thus needs to be combined with another drug. Meperidine also reduces the shivering threshold. We therefore determined whether the combination of nefopam and meperidine is additive, infra-additive, or synergistic on the shivering threshold. METHODS: Ten volunteers were each studied on 4 randomly assigned days. In random order, they were given the following treatments: (1) control, no drug; (2) nefopam to a target concentration of 0.1 µg/mL; (3) meperidine to a target concentration of 0.1 µg/mL; and (4) both nefopam and meperidine at target concentrations of 0.1 µg/mL each. Lactated Ringer's solution at 4°C was infused to decrease core temperature while mean skin temperature was kept near 30.5°C. The core temperature that increased oxygen consumption >25% defined the shivering threshold. RESULTS: Nefopam reduced the shivering thresholds by 0.7°C ± 0.3°C compared with no drug. Meperidine reduced the shivering thresholds by 0.4°C ± 0.3°C compared with no drug. When combined, the shivering threshold decreased by only 0.6°C ± 0.4°C, which was about half what would have been expected based on the individual effects of each drug (P < 0.001). The effect of combined nefopam and meperidine on the shivering threshold was thus infra-additive. CONCLUSIONS: The combination of nefopam and meperidine should be avoided for induction of therapeutic hypothermia. Better options would be combinations of drugs that are at least additive or even synergistic.


Assuntos
Hipotermia Induzida/efeitos adversos , Meperidina/administração & dosagem , Nefopam/administração & dosagem , Tremor por Sensação de Frio/efeitos dos fármacos , Adulto , Sinergismo Farmacológico , Quimioterapia Combinada , Humanos , Meperidina/efeitos adversos , Nefopam/efeitos adversos
8.
J Int Med Res ; 42(3): 684-92, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24691459

RESUMO

OBJECTIVE: The efficacy and side-effects of nefopam were prospectively compared with those of fentanyl for patient-controlled analgesia (PCA) following cardiac surgery. METHODS: Patients scheduled to undergo cardiac surgery were randomly assigned between three PCA groups (nefopam, fentanyl or nefopam + fentanyl). Pain was assessed at rest and during movement at 12, 24, 36, 48 and 72 h after surgery using a visual analogue scale (VAS). Total infused PCA volume, number of rescue drug injections, duration of intubation and length of stay in the intensive care unit were recorded. The incidence of adverse effects was noted at 48 h postoperatively. RESULTS: There were no significant between-group differences in VAS score, total PCA infusion volume or number of rescue injections (n = 92 per group). Nausea was significantly more common in the fentanyl group compared with both other groups. CONCLUSIONS: PCA with nefopam alone provides suitable postoperative analgesia after cardiac surgery.


Assuntos
Analgésicos não Entorpecentes/administração & dosagem , Analgésicos Opioides/administração & dosagem , Procedimentos Cirúrgicos Cardíacos , Fentanila/administração & dosagem , Nefopam/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgesia Controlada pelo Paciente/métodos , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos Opioides/efeitos adversos , Método Duplo-Cego , Feminino , Fentanila/efeitos adversos , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Náusea/etiologia , Náusea/fisiopatologia , Nefopam/efeitos adversos , Medição da Dor , Dor Pós-Operatória/fisiopatologia , Estudos Prospectivos
9.
Anesteziol Reanimatol ; (1): 40-3, 2014.
Artigo em Russo | MEDLINE | ID: mdl-24749308

RESUMO

MATERIALS AND METHODS: 83 adult patients included in the study were divided into two groups. Patients of the group-1 (n-49) had medium level of pain after cancer head and neck surgery. Patients of the group-2 (n-34) had severe pain. Three first postoperative days their post-operative multimodal analgesia started with tenoxycam 20 mg i.m. after induction of anesthesia, then every 24 hour (58 patients). 25 patients got ketoprofen 100 mg i.m. every 8-12 hours instead of tenoxycam. All patients had nefopam 30 mg i.m. 30 min prior the end of surgery procedure, and every 8 hours afterwards. 7 patients of the group-1 had more than 4 pain scores (day 1), 4 patients--at the day 2. They received tramadol or paracetamol additionally. 7 patients (group-2) also had up to 5 pain scores on the day 1, 5 patients had 4 pain scores on the day 2, and 3 patients 4 pain scores on the day 3. All that patients received additional analgesia with tramadol or trimeperidine once a day. 8.4% of patients suffered from adverse reactions (tachycardia, PONV and sweating). CONCLUSION: This method of multimodal postoperative analgesia is very simple and fairly efficient.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Neoplasias de Cabeça e Pescoço/cirurgia , Cetoprofeno/uso terapêutico , Nefopam/uso terapêutico , Dor Pós-Operatória/prevenção & controle , Piroxicam/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , Esquema de Medicação , Quimioterapia Combinada , Humanos , Cetoprofeno/administração & dosagem , Cetoprofeno/efeitos adversos , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Medição da Dor , Piroxicam/administração & dosagem , Piroxicam/efeitos adversos , Piroxicam/uso terapêutico , Procedimentos Cirúrgicos Operatórios/métodos , Resultado do Tratamento , Adulto Jovem
10.
Anesteziol Reanimatol ; 59(5): 27-32, 2014.
Artigo em Russo | MEDLINE | ID: mdl-25842937

RESUMO

OBJECTIVE: To develop effective and safe measures of postoperative multimodal analgesia (optimizing the use of narcotic analgesics) in surgical treatment of hematological patients with thrombocytopenia. DESIGN: A pilot and prospective comparative controlled study. METHODS: We studied 27 patients with acquired thrombocytopenia who underwent laparoscopic splenectomy. Three schemes of anesthesia were used: 1) Nefopam 20 mg/day + trimeperidin (n = 7); 2) Paracetamol 4 g/day + trimeperidin (n = 10); 3) paracetamol + trimeperidin + glucocorticosteroids (GC) (through treatment of the underlying disease) (n = 10). Analgesic properties and effect of each scheme were assessed according to a rating scale of pain NRS (10 points) and VAS (100 points) studied. Additionally we evaluated the effect of nefopam and paracetamol on the functional properties of platelets and hemostasis, platelet levels while monitoring and indicators of thromboelastogram (TEG). RESULTS: Application of paracetamol + trimeperidin accompanied with effectively reducing of postoperative pain (less than 5 points on the NRS). The level of postoperative pain was lower in patients who were treated with corticosteroids within the therapy of the underlying disease before surgery and who continued to receive it in postoperative period (2-3 points NRS). Nefopam use in the perioperative period is not only inferior to the analgesic effect of paracetamol, but also causes frequent side effects. Consumption of narcotic analgesic--trimeperidin when applying nefopam averaged 43 mg/day, the appointment of paracetamol--28 mg/day, using a combination of paracetamol + GC--20 mg/day. Thus, GC within the underlying disease treatment substantially reduces the need for opioid analgesics. A monitoring of the number of platelets and TEG did not shows negative effect of paracetamol and nefopam on platelet and plasma hemostasis. CONCLUSIONS: Nefopam and paracetamol may be used in patients with thrombocytopenia, as do not affect the hemostasis and platelet count. Application of postoperative analgesia scheme paracetamol + trimeperidin in patients receiving corticosteroids provides the maximum reduction of pain with the least consumption of narcotic analgesics.


Assuntos
Analgesia/métodos , Analgésicos não Entorpecentes/uso terapêutico , Analgésicos Opioides/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Esplenectomia , Trombocitopenia/cirurgia , Acetaminofen/administração & dosagem , Acetaminofen/efeitos adversos , Acetaminofen/uso terapêutico , Adulto , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Plaquetas/citologia , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Nefopam/uso terapêutico , Contagem de Plaquetas , Promedol/administração & dosagem , Promedol/efeitos adversos , Promedol/uso terapêutico , Trombocitopenia/sangue
11.
Int J Med Sci ; 10(12): 1790-4, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24273453

RESUMO

OBJECTIVES: The aim of this study was to investigate if there is any interaction between ondansetron and nefopam when they are continuously co-administrated during patient-controlled intravenous analgesia (PCIA). METHODS: The study was a prospective, randomized, controlled, non-inferiority clinical trial comparing nefopam-plus-ondansetron to nefopam alone. A total of 230 postoperative patients using nefopam for PCIA, were randomly assigned either to a group receiving continuous infusion of ondansetron (Group O) or to the other group receiving the same volume of normal saline continuously (Group N). Postoperative pain intensity scores, the sum of pain intensity difference over 24 hours postoperatively (SPID24hr), the incidence of adverse events, and the total consumption of nefopam were evaluated respectively. RESULTS: Postoperative pain was treated successfully in both groups. The mean SPID24hr scores were 95.6 mm in Group N and 109.3mm in Group O [95% confidence interval (CI) -14.28, 24.32]. The lower margin of the 95% CI was above the pre-determined non-inferiority margin (-30mm) for SPID24hr, which indicated that nefopam-plus-ondansetron was not worse than the nefopam alone in term of analgesic efficacy. In addition, there was no statistical difference between the two groups in term of cumulative consumption of nefopam. Compared with Group N, postoperative vomiting was significantly reduced in Group O during the postoperative 24 hours (P < 0.05). Less rescue antiemetics were given to patients in Group O than those receiving nefopam alone (P < 0.05). There were no differences in postoperative nausea between the two groups. CONCLUSION: Nefopam-plus-ondansetron is not inferior to nefopam alone in relieving the pain in PCIA after minimally invasive surgery. In addition, adverse events are reduced without compromising analgesic efficacy.


Assuntos
Nefopam/administração & dosagem , Ondansetron/administração & dosagem , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológico , Adulto , Idoso , Analgésicos/administração & dosagem , Combinação de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nefopam/efeitos adversos , Ondansetron/efeitos adversos , Dor Pós-Operatória/patologia , Estudos Prospectivos
12.
Anesteziol Reanimatol ; (2): 78-82, 2013.
Artigo em Russo | MEDLINE | ID: mdl-24000658

RESUMO

A prospective, randomized, comparative study was conducted. 3 analgesia protocols were used: 1) patient controlled analgesia (PCA) with trimeperidine in combination with a nefopam constant infusion; 2) PCA with trimeperidine in combination with a nefopam bolus; 3) PCA with trimeperidine separately during early postoperative period in cardiac surgery patients. The study included 60 patients agedf rom 40 to 65 years of age (20 patients in each group). The analgesia efficacy was evaluated with a 5-point verbal rating scale (VRS) for pain intensity and inspiratory lung capacity (ILC), measured with incentive spirometer. The safety of nefopam during early postoperative period in cardiac surgery patients was shown. The combination of nefopam and trimeperidine led to a more pronounced analgetic effect. Trimeperidine consumption was significantly lower in nefopam groups than in the group of isolated PCA. Wholly adverse effects were associated with trimeperidine and were dose-related The incidence of nausea, vomiting, dizziness, weakness, bowel paresis was significantly higher in isolated PCA group than in the other two groups.


Assuntos
Analgesia/métodos , Analgésicos não Entorpecentes/uso terapêutico , Procedimentos Cirúrgicos Cardíacos , Nefopam/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/métodos , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Medição da Dor , Promedol/administração & dosagem , Promedol/efeitos adversos , Promedol/uso terapêutico , Estudos Prospectivos , Resultado do Tratamento
13.
Ann Fr Anesth Reanim ; 32(9): e113-5, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23867540

RESUMO

Acute glaucoma angle closure is a rare complication of anaesthesia and multimodal analgesia. However it is a medical emergency, hence any delay in its treatment may have catastrophic consequences. We present a case of postoperative glaucoma, which had evolved to permanent blindness. We also reviewed the French pharmacovigilance database between 1996 and 2006 and found four other cases of acute glaucoma angle closure in postoperative period possibly related to the administration of nefopam.


Assuntos
Analgésicos não Entorpecentes/efeitos adversos , Cegueira/induzido quimicamente , Nefopam/efeitos adversos , Idoso , Anestesia Geral , Artroplastia do Joelho , Cegueira/fisiopatologia , Feminino , Glaucoma de Ângulo Fechado/induzido quimicamente , Humanos , Bloqueio Nervoso , Doenças do Nervo Óptico/induzido quimicamente , Medição da Dor , Dor Pós-Operatória/complicações , Dor Pós-Operatória/tratamento farmacológico , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/fisiopatologia
14.
Anesteziol Reanimatol ; (5): 11-5, 2013.
Artigo em Russo | MEDLINE | ID: mdl-24624851

RESUMO

4 combinations of analgesia were studied: 1) Nefopam and patient-controlled analgesia (PCA) with Trimeperidine; 2) Ketoprofen (100 microg each 12 hours intramuscular) and PCA with Trimeperidine; 3) Nefopam, Ketoprofen and PCA with Trimeperidine; 4) PCA with Trimeperidine as monotherapy in early postoperative period in cardio-surgical patients. 80 patients (age from 40 to 70) were divided into 4 groups, 20 patients in each group. Administration of Nefopam and Ketoprofen before extubation reduced the intensity of pain syndrome (in average on 90%) and promoted the early stirring up of patients. Combination of Nefopam and Ketoprofen provided the most expressed analgesic and opioids-saving effects. In this group average amount of Trimeperidine per 24 hours was 14.7 microg that was 4.9 times less than in group of PCA with Trimeperidine as monotherapy. Dynamics of maximal inspiratory capacity of the lungs in the first three groups was better than in group of PCA with Trimeperidine as monotherapy beginning from 6th hour of study. In common undesirable effects was connected with Trimeperidine administration and depended on its dose. The frequency of nausea, vomit, dizziness and weakness was authentically higher in the group of PCA with Trimeperidine as monotherapy than in other groups.


Assuntos
Analgésicos não Entorpecentes/uso terapêutico , Analgésicos Opioides/uso terapêutico , Procedimentos Cirúrgicos Cardíacos , Cetoprofeno/uso terapêutico , Nefopam/uso terapêutico , Dor Pós-Operatória/prevenção & controle , Promedol/uso terapêutico , Adulto , Idoso , Analgesia Controlada pelo Paciente , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Humanos , Cetoprofeno/administração & dosagem , Cetoprofeno/efeitos adversos , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Promedol/administração & dosagem , Promedol/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
15.
Minerva Anestesiol ; 79(3): 232-9, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23241734

RESUMO

BACKGROUND: The analgesic efficacy of nefopam and of paracetamol has been shown in the postoperative period after mild- and moderate-pain surgery. The aim of this study was to define the median effective analgesic doses of each drug and of their combination, in order to determine the nature of their interaction. METHODS: Ninety adult patients scheduled to undergo tonsillectomy under general anesthesia were enrolled in one out of three groups: nefopam group, or paracetamol group, or nefopam-paracetamol group. The median effective dose for each drug and also for their combination was defined using an up-and-down sequential allocation technique. The analgesic interaction of their combination was assessed using an isobolographic analysis. RESULTS: The median effective analgesic dose (median value and 95% confidence interval) of nefopam and paracetamol were 21.7 mg (21.1-22.3 mg) and 628 mg (600-656 mg), respectively. The median effective analgesic doses of the combination were 8.9 mg (8.7-9.1 mg) for nefopam and 265 mg (256-274 mg) for paracetamol. The isobolographic analysis demonstrated a supra-additive interaction of the two drugs. CONCLUSION: The combination of nefopam and paracetamol produces effective analgesia with a synergistic interaction.


Assuntos
Acetaminofen/administração & dosagem , Acetaminofen/uso terapêutico , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/uso terapêutico , Nefopam/administração & dosagem , Nefopam/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Acetaminofen/efeitos adversos , Adulto , Analgésicos não Entorpecentes/efeitos adversos , Anestesia Geral , Relação Dose-Resposta a Droga , Método Duplo-Cego , Sinergismo Farmacológico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nefopam/efeitos adversos , Tonsilectomia
16.
J Rheumatol Suppl ; 90: 28-33, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22942326

RESUMO

OBJECTIVE: To determine the efficacy and safety of neuromodulators for pain management in patients with inflammatory arthritis. METHODS: A Cochrane systematic review was performed as part of the 3e Initiative on pain management in inflammatory arthritis. We searched Medline, Embase, and Cochrane Central for studies to November 2010, and American College of Rheumatology/European League Against Rheumatism meeting abstracts published in 2008-2009. Studies were included if they were randomized or quasirandomized controlled trials that compared any neuromodulator (excluding cannabis) to another therapy (active or placebo, including nonpharmacological therapies) for pain in patients with RA, psoriatic arthritis, ankylosing spondylitis, or spondyloarthritis. Primary outcomes of interest were patient-reported pain relief of 30% or greater and withdrawals due to adverse events. Two authors independently extracted data and assessed methodological quality. A risk of bias assessment was performed using the methods recommended by the Cochrane Collaboration. RESULTS: Three trials, all in RA and all at high risk of bias, were included in this review. Two placebo-controlled trials evaluated nefopam (52 participants) and one placebo-controlled trial evaluated topical capsaicin 0.025% (31 participants). Pooled analysis showed a significant reduction in pain levels favoring nefopam over placebo after 2 weeks [weighted mean difference -21.2, 95% CI -35.6 to -6.7; number needed to treat (NNT) 2, 95% CI 1.4 to 9.5]. However, nefopam was associated with significantly more adverse events (RR 4.1, 95% CI 1.6 to 10.7; number needed to harm 9, 95% CI 2 to 367), predominantly nausea and sweating. In one trial, capsaicin reduced pain more than placebo at 1 and 2 weeks (MD -23.8, 95% CI -44.8 to -2.8; NNT 3, 95% CI 2-47, and -34.4, 95% CI -54.7 to -14.14; NNT 2, 95% CI 1.4 to 6, respectively). Of those who received capsaicin, 44% developed burning at the site of application and 2% withdrew as a result. CONCLUSION: Based on 3 small trials, which were all at high risk of bias, there is weak evidence that nefopam and capsaicin are superior to placebo in reducing pain in patients with RA, but both are associated with a significant side effect profile. There are no available data for other types of IA or for newer agents such as gabapentin or pregabalin.


Assuntos
Analgésicos não Entorpecentes/uso terapêutico , Artrite/tratamento farmacológico , Capsaicina/uso terapêutico , Nefopam/uso terapêutico , Neurotransmissores/uso terapêutico , Manejo da Dor/métodos , Dor/tratamento farmacológico , Analgésicos não Entorpecentes/efeitos adversos , Artrite/complicações , Capsaicina/efeitos adversos , Medicina Baseada em Evidências , Prova Pericial , Humanos , Cooperação Internacional , Nefopam/efeitos adversos , Dor/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
17.
Cochrane Database Syst Rev ; 1: CD008921, 2012 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-22258992

RESUMO

BACKGROUND: Pain management is a high priority for patients with rheumatoid arthritis (RA). Despite deficiencies in research data, neuromodulators have gained widespread clinical acceptance as adjuvants in the management of patients with chronic musculoskeletal pain. OBJECTIVES: The aim of this review was to determine the efficacy and safety of neuromodulators in pain management in patients with RA. Neuromodulators included in this review were anticonvulsants (gabapentin, pregabalin, phenytoin, sodium valproate, lamotrigine, carbamazepine, levetiracetam, oxcarbazepine, tiagabine and topiramate), ketamine, bupropion, methylphenidate, nefopam, capsaicin and the cannabinoids. SEARCH METHODS: We performed a computer-assisted search of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, 4th quarter), MEDLINE (1950 to week 1 November 2010), EMBASE (Week 44, 2010) and PsycINFO (1806 to week 2 November 2010). We also searched the 2008 and 2009 American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) conference abstracts and performed a handsearch of reference lists of articles. SELECTION CRITERIA: We included randomised controlled trials which compared any neuromodulator to another therapy (active or placebo, including non-pharmacological therapies) in adult patients with RA that had at least one clinically relevant outcome measure. DATA COLLECTION AND ANALYSIS: Two blinded review authors independently extracted data and assessed the risk of bias in the trials. Meta-analyses were used to examine the efficacy of a neuromodulator on pain, depression and function as well as their safety. MAIN RESULTS: Four trials with high risk of bias were included in this review. Two trials evaluated oral nefopam (52 participants) and one trial each evaluated topical capsaicin (31 participants) and oromucosal cannabis (58 participants).The pooled analyses identified a significant reduction in pain levels favouring nefopam over placebo (weighted mean difference (WMD) -21.16, 95% CI -35.61 to -6.71; number needed to treat (NNT) 2, 95% CI 1.4 to 9.5) after two weeks. There were insufficient data to assess withdrawals due to adverse events. Nefopam was associated with significantly more adverse events (RR 4.11, 95% CI 1.58 to 10.69; NNTH 9, 95% CI 2 to 367), which were predominantly nausea and sweating.In a mixed population trial, qualitative analysis of patients with RA showed a significantly greater reduction in pain favouring topical capsaicin over placebo at one and two weeks (MD -23.80, 95% CI -44.81 to -2.79; NNT 3, 95% CI 2 to 47; MD -34.40, 95% CI -54.66 to -14.14; NNT 2, 95% CI 1.4 to 6 respectively). No separate safety data were available for patients with RA, however 44% of patients developed burning at the site of application and 2% withdrew because of this.One small, low quality trial assessed oromucosal cannabis against placebo and found a small, significant difference favouring cannabis in the verbal rating score 'pain at present' (MD -0.72, 95% CI -1.31 to -0.13) after five weeks. Patients receiving cannabis were significantly more likely to suffer an adverse event (risk ratio (RR) 1.82, 95% CI 1.10 to 3.00; NNTH 3, 95% CI 3 to 13). These were most commonly dizziness (26%), dry mouth (13%) and light headedness (10%). AUTHORS' CONCLUSIONS: There is currently weak evidence that oral nefopam, topical capsaicin and oromucosal cannabis are all superior to placebo in reducing pain in patients with RA. However, each agent is associated with a significant side effect profile. The confidence in our estimates is not strong given the difficulties with blinding, the small numbers of participants evaluated and the lack of adverse event data. In some patients, however, even a small degree of pain relief may be considered worthwhile. Until further research is available, given the relatively mild nature of the adverse events, capsaicin could be considered as an add-on therapy for patients with persistent local pain and inadequate response or intolerance to other treatments. Oral nefopam and oromucosal cannabis have more significant side effect profiles however and the potential harms seem to outweigh any modest benefit achieved.


Assuntos
Artralgia/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Neurotransmissores/uso terapêutico , Administração Oral , Administração Tópica , Adulto , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos não Entorpecentes/uso terapêutico , Artralgia/etiologia , Artrite Reumatoide/complicações , Canabinoides/efeitos adversos , Canabinoides/uso terapêutico , Cannabis/química , Capsaicina/efeitos adversos , Capsaicina/uso terapêutico , Depressão/tratamento farmacológico , Humanos , Nefopam/efeitos adversos , Nefopam/uso terapêutico , Neurotransmissores/efeitos adversos , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Br J Anaesth ; 106(3): 336-43, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21205626

RESUMO

BACKGROUND: Pain management is challenging in intensive care unit (ICU) patients. The analgesic efficacy, tolerance, and haemodynamic effects of nefopam have never been described in critically ill patients. METHODS: In consecutive medical-surgical ICU patients who received 20 mg of nefopam i.v. over 30 min, we measured pain, Richmond Agitation Sedation Scale (RASS), respiratory parameters, and adverse drug events at T0 (baseline), T30 (end-of-infusion), T60, and T90 min. Haemodynamic variables were assessed every 15 min from T0 to T60 and T90. Pain was evaluated by the behavioural pain scale (BPS, 3-12) or by the self-reported visual numeric rating scale (NRS, 0-10) according to communication capacity. RESULTS: Data were analysed for 59 patients. As early as T30, median NRS and BPS decreased significantly from T0 to a minimum level at T60 for NRS [5 (4-7) vs 1 (1-3), P<0.001] and T90 for BPS [5 (5-6) vs 3 (3-4), P<0.001]. No significant changes were detected for RASS, ventilatory frequency, or oxygen saturation. Increased heart rate and decreased mean arterial pressure, defined as a change ≥15% from baseline, were found in 29% and 27% of patients, respectively. For the 18 patients monitored, cardiac output increased by 19 (7-29)% and systemic vascular resistance decreased by 20 (8-28)%, both maximally at T30. Heat sensation, nausea/vomiting, sweating, and mouth dryness were found, respectively, in 6%, 9%, 22%, and 38% of patients. CONCLUSIONS: A single slow infusion of nefopam is effective in critically ill patients who have moderate pain. The risk of tachycardia and increased cardiac output and also hypotension and decreased systemic vascular resistance should be known to evaluate the benefit/risk ratio of its prescription.


Assuntos
Analgésicos não Entorpecentes/uso terapêutico , Estado Terminal/terapia , Nefopam/uso terapêutico , Dor/tratamento farmacológico , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/efeitos adversos , Débito Cardíaco/efeitos dos fármacos , Cuidados Críticos/métodos , Feminino , Frequência Cardíaca/efeitos dos fármacos , Hemodinâmica/efeitos dos fármacos , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Medição da Dor/métodos , Estudos Prospectivos
19.
Anesth Analg ; 111(5): 1146-53, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20971961

RESUMO

BACKGROUND: Treatment of intense postoperative pain in patients with end-stage renal disease (ESRD) is a recurrent problem for anesthesiologists because of the risk of accumulation of numerous molecules and their metabolites. Nefopam is a potent analgesic metabolized by the liver and weakly eliminated intact in urine that may offer advantages for use in patients with ESRD because it lacks respiratory-depressive effects. However, the effects of renal failure on nefopam disposition have never been investigated. METHODS: We studied 12 ESRD patients (creatinine clearance < 20 mL/min, mean age 57 ± 13 years) having surgery under general anesthesia to create or repair an arteriovenous fistula. Postoperatively, after complete recovery from anesthesia, each patient received a single 20-mg dose of nefopam IV over 30 minutes. Nefopam and desmethyl-nefopam concentrations in plasma samples obtained over 48 hours were determined by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameter values obtained were compared with those of 12 healthy 50- to 60-year-old volunteers who also received a single 20-mg nefopam infusion over 30 minutes using a population pharmacokinetic approach. RESULTS: Healthy volunteers and ESRD patients had comparable demographic characteristics. In comparison with those volunteers, ESRD patients had a lower volume of central compartment (115 and 53 L vs. 264 L for patients not yet hemodialyzed and on chronic hemodialysis, respectively; P < 0.001) and lower mean nefopam clearance (37.0 and 27.3 L/h vs. 52.9 L/h, P < 0.001), resulting in higher mean nefopam peak concentration (121 and 223 ng/mL vs. 61 ng/mL, P < 0.001). CONCLUSIONS: Nefopam distribution and elimination are altered in patients with ESRD, resulting in heightened exposure. To avoid too-high concentration peaks, it is suggested that the daily nefopam dose be reduced by 50%.


Assuntos
Analgésicos não Entorpecentes/farmacocinética , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Falência Renal Crônica/terapia , Nefopam/farmacocinética , Dor Pós-Operatória/prevenção & controle , Diálise Renal , Adulto , Idoso , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/efeitos adversos , Analgésicos não Entorpecentes/sangue , Biotransformação , Cromatografia Líquida , Feminino , França , Humanos , Infusões Intravenosas , Falência Renal Crônica/sangue , Masculino , Pessoa de Meia-Idade , Modelos Biológicos , Nefopam/administração & dosagem , Nefopam/efeitos adversos , Nefopam/análogos & derivados , Nefopam/sangue , Dor Pós-Operatória/etiologia , Espectrometria de Massas em Tandem , Resultado do Tratamento
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