scholarly journals A randomized-controlled, double-blind comparison of the postoperative analgesic efficacy of caudal bupivacaine and levobupivacaine in minor pediatric surgery

2014 ◽  
Vol 66 (6) ◽  
pp. 457 ◽  
Author(s):  
Ahmet Sen ◽  
Mehmet Salih Colak ◽  
Engin Erturk ◽  
Yakup Tomak
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020


1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).


2018 ◽  
Vol 22 (9) ◽  
pp. 2981-2988 ◽  
Author(s):  
Maria Victoria Olmedo-Gaya ◽  
Francisco Javier Manzano-Moreno ◽  
Jose Luis Muñoz-López ◽  
Manuel Francisco Vallecillo-Capilla ◽  
Candela Reyes-Botella

Medicina ◽  
2021 ◽  
Vol 57 (4) ◽  
pp. 316
Author(s):  
Ki Tae Jung ◽  
Keum Young So ◽  
Seung Chul Kim ◽  
Sang Hun Kim

Background and Objectives: We investigated the non-inferiority of patient-controlled analgesia (PCA), using either nefopam alone or combined nefopam-fentanyl for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized, controlled study, 78 patients were allocated to receive nefopam 240 mg (Group N240) or nefopam 120 mg with fentanyl 600 μg (Group NF), equivalent to fentanyl 1200 μg, with a total PCA volume of 120 mL. Patients were given a loading dose (0.1 mL/kg) from the PCA device along with ramosetron (0.3 mg) and connected to a PCA device with a background infusion rate of 2 mL/h, bolus dose amount set at 2 mL, and lockout interval set at 15 min. Pain scores were obtained using the numeric rating scale (NRS) at 30 min after recovery room (RR) admission, as well as 8 and 24 h postoperatively. The primary outcome was analgesic efficacy evaluated using NRS-rated 8 h postoperatively. Other evaluated outcomes included the incidence rate of bolus demand, rescue analgesic and antiemetic requirements, and postoperative adverse effects. Results: NRS scores were not significantly different between the groups throughout the postoperative period (p = 0.539). NRS scores of group N240 were not inferior to those of group NF at 30 min after RR admission, or at 8 and 24 h postoperatively (mean difference [95% CI], −0.05 [−0.73 to 0.63], 0.10 [−0.29 to 0.50], and 0.28 [−0.06 to 0.62], respectively). Postoperative adverse effects were not significantly different between the two groups (p = 1.000) and other outcomes were also not significantly different between the two groups (p ≥ 0.225). Conclusions: PCA using nefopam alone has a non-inferior and effective analgesic efficacy and produces a lower incidence of postoperative adverse effects compared to a combination of fentanyl and nefopam after laparoscopic cholecystectomy.


1974 ◽  
Vol 2 (3) ◽  
pp. 228-235 ◽  
Author(s):  
S S Bedi

In a double-blind short term cross-over study, designed to evaluate the analgesic efficacy of alclofenac, 500 mg thrice daily against aspirin, 866 mg thrice daily, fifty patients in a chronic stage of classical or definite rheumatoid arthritis (according to American Rheumatism Association ( 1959) criteria) were selected. The criteria of assessment included pain, function and morning stiffness. The patients' and physician's overall preferences and opinion on tolerance were also recorded. Forty-eight patients completed the study successfully. The study showed that both drugs were significantly effective in relieving pain but there was no difference between the two preparations and neither drug made any improvement to function or morning stiffness. The patients' and physician's preferences and opinion on the therapeutic efficacy were almost equally divided between the two drugs. However, the instances of side-effects were a little higher ( 44%) with aspirin than with alclofenac ( 34%). It appears from this study that in chronic rheumatoid arthritis the analgesic activity of 1·5 g alclofenac is equivalent to 2·6 g (approx.) of aspirin.


1982 ◽  
Vol 10 (6) ◽  
pp. 408-413 ◽  
Author(s):  
C E Parker ◽  
A F Langrick

In a double-blind study the analgesic efficacy and acceptability of meptazinol 200 mg was compared with placebo in patients suffering from acute or chronic pain. Patients were randomly allocated to receive either 200 mg of meptazinol or one tablet of placebo 4 to 6 hourly over a 14-day period. Clinical evaluations were made by the physician at baseline and again at the end of the study. The patients made daily recordings of pain using a visual analogue scale. The results showed that meptazinol was a more effective and acceptable analgesic than placebo. There was no significant difference in the incidence of adverse effects reported by patients in either treatment group.


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