scholarly journals Comparison of Postoperative Analgesic Effects Between Nalbuphine and Fentanyl in Children Undergoing Adenotonsillectomy: A Prospective, Randomized, Double-Blind, Multicenter Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Fang Chen ◽  
Cheng-Yu Wang ◽  
Jianmin Zhang ◽  
Fang Wang ◽  
Mazhong Zhang ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Double Blind ◽  
Rescue Dose ◽  
Analgesic Effects ◽  
Extubation Time ◽  
Medical Facilities ◽  
The Mean ◽  
Waking Up ◽  
Pacu Stay ◽  
Fentanyl Group

Objective: There is no universal agreement on optimal pharmacological regimens for pain management during surgeries. The aim of this study to compare the postoperative analgesic effects of nalbuphine with fentanyl in children undergoing adenotonsillectomy.Design, Setting, Participants: We conducted a prospective, randomized, double-blind, non-inferiority and multicenter trial in 311 patients admitted to four different medical facilities in China from October 2017 to November 2018.Main Outcome Measure: The primary outcome was postoperative pain score. The secondary outcomes were as follows: the numbers of patients who developed moderate or severe pain (FLACC ≥4 points); time to first rescue analgesic top up and the actual number of rescue pain medicine given in pain control in post-anesthesia care unit (PACU), and additional analgesics requirement (received ≥2 rescue analgesics or/and other analgesics except study medications administered in PACU and ward); emergence and extubation time; Waking up time; time of PACU stay, and other side effects (desaturation, nausea/vomiting etc.).Results: A total of 356 children were screened and 322 patients were randomized. The mean age was 5.8 (5.5, 6.1) in the nalbuphine group and 5.6 (5.3, 5.8) in the fentanyl group (p = 0.2132). FLACC score of nalbuphine group was lower than that of fentanyl group upon patients' arrival at PACU (p < 0.05). The time to first required rescue dose of pain drug for nalbuphine group was longer than for the fentanyl group (2.5 vs 1.2 h, p < 0.0001). Only one patient (0.6%) in nalbuphine group presented a slow respiratory rate (RR) at 9/min while 29 patients (18.5%) in fentanyl group developed slow RR ≤10/min in PACU. Meanwhile, SpO2 was lower in the fentanyl group at 10 min after patients’ arrival in PACU (p < 0.05). The other profiles observed from these two drug groups were similar.Conclusion: Nalbuphine provided better pain relief with minimal respiration depression than fentanyl in children undergoing Adenotonsillectomy.

scholarly journals Comparative Study of 0.2% Glyceryl Trinitrate Ointment for Pain Reduction after Hemorrhoidectomy Surgery

2019 ◽  
Vol 05 (04) ◽  
pp. e192-e196 ◽  
Author(s):  
Sepideh Vahabi ◽  
Siavash Beiranvand ◽  
Arash Karimi ◽  
Mahmoudreza Moradkhani
Keyword(s):  
Glyceryl Trinitrate ◽  
Controlled Study ◽  
Analog Scale ◽  
Double Blind ◽  
Mean Values ◽  
Analgesic Effects ◽  
Total Pain ◽  
Significant Difference ◽  
The Mean ◽  
Glyceryl Trinitrate Ointment

Abstract Context Hemorrhoid is one of the most common diseases in both, men and women, affecting half of the world's population over the age of 50. Aims The aim of this study was to evaluate the analgesic effects of local ointment of glyceryl trinitrate ointment (GTN) after hemorrhoidectomy. Methods and Materials In this randomized double-blind, placebo-controlled study, the patients were grouped as the treatment, that is GTN, and placebo (P) group. After surgery, 0.2% gelatin GTN ointment (250 mg), and P ointment (n = 20 for each group) were applied topically on 1 cm on the anus using a standard ruler, three times a week in respective groups. visual analog scale was used to assess the intensity of the pain and complications of the drugs were observed at 6, 12, 18, and 24 hours. Statistical Analysis Used Data and questionnaires were analyzed statistically using SPSS17 software and results were recorded in the tabular form. Results Six hours after the application of the ointment, no significant difference was found among the groups, however, after 12, 18, and 24 hours significant reduction in pain was seen in GTN group, which was least after 18 hours. The mean values of the total pain score in the first 24 hours after surgery in the GTN group were 3.15 and 5.45 in the P group which were statistically significant. Nonetheless, headache was significantly increased in the GTN group. Conclusion Simple and safe topical GTN ointment can reduce the pain after hemorrhoidectomy, leading to the reduced need of other analgesics.

Placental Transfer and Neonatal Effects of Epidural Sufentanil and Fentanyl Administered with Bupivacaine during Labor

1995 ◽  
Vol 83 (2) ◽  
pp. 300-308. ◽  
Author(s):  
John R. Loftus ◽  
Harlan Hill ◽  
Sheila E. Cohen
Keyword(s):  
Placental Transfer ◽  
Plasma Concentrations ◽  
Double Blind ◽  
Epidural Bupivacaine ◽  
Neurobehavioral Testing ◽  
Neonatal Assessment ◽  
The Mean ◽  
Blood Gas Analyses ◽  
Group B ◽  
Fentanyl Group

Background This randomized double-blind investigation was designed to study the placental transfer and neonatal effects of epidural sufentanil and fentanyl infused with bupivacaine for labor analgesia. Methods Healthy parturient women (n = 36) received epidural bupivacaine alone (group B) or with fentanyl (group B-F) or sufentanil (group B-S). Group B received a 12-ml bolus of 0.25% bupivacaine followed by a 10 ml/h infusion of 0.125% bupivacaine. Groups B-F and B-S received a 12-ml bolus of 0.125% bupivacaine with 75 micrograms fentanyl or 15 micrograms sufentanil, respectively, followed by 10 ml/h of 0.125% bupivacaine with fentanyl 1.5 micrograms/ml or sufentanil 0.25 micrograms/ml. Maternal venous (MV) and umbilical arterial (UA) and umbilical venous (UV) bupivacaine and opioid plasma concentrations were determined. Neonatal assessment included Apgar scores, umbilical cord blood gas analyses, and neurobehavioral testing at delivery and at 2 and 24 h of life using the Neurologic and Adaptive Capacity Score (NACS). Results The mean total dose of fentanyl was 136.6 +/- 13.1 micrograms (SEM), and of sufentanil, 23.8 +/- 1.8 micrograms. Although administered in a ratio of 5.7:1, fentanyl and sufentanil MV plasma concentrations were in the ratio of 27:1. UV/MV ratios were 0.37 for fentanyl and 0.81 for sufentanil. Fentanyl was detected in most UA samples, whereas sufentanil was present in only one sample. Neonatal condition was good and generally similar in all groups, with the exception of a lower NACS at 24 h in group B-F. Conclusions Although the degree of placental transfer of sufentanil appeared greater than that of fentanyl, lower MV sufentanil concentrations resulted in less fetal exposure to sufentanil. The lower NACS at 24 h in group B-F may reflect the continued presence of fentanyl in the neonate.

scholarly journals Using Local Nigella Sativa Oil to Relief Premenstrual Syndrome Symptoms

2021 ◽  
Author(s):  
Ezat Samadipour ◽  
Roya Akbarzadeh ◽  
Akram Kooshki
Keyword(s):  
Premenstrual Syndrome ◽  
Nigella Sativa ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Double Blind ◽  
Analgesic Effects ◽  
Nigella Sativa Oil ◽  
Double Blind Clinical Trial ◽  
Analgesic Supplement ◽  
The Mean

Background: Premenstrual Syndrome (PMS) is a common problem in women. Nigella sativa has been suggested for its anti-inflammation and analgesic effects. This study was conducted to evaluate the effect of Nigella sativa oil on PMS. Methods: This double-blind clinical trial was conducted on 124 female students within the age range of 18-25 years living in the dormitories of Sabzevar University of Medical Sciences. Participants were randomly divided into two groups. The intervention group (IG) rubbed 1-2 drops of Nigella sativa oil on their fontanels at night for sev­en days before their three menstrual cycles. The placebo group (PG) rubbed placebo in the same way. After three cycles, pain severity was measured by the visual analog scale. Data analysis was carried out using the Mann-Whitney U test and analysis of covariance. Results: The mean age of participants, the mean age of menarche, and the mean age of PMS onset were 20.55 ± 0.2, 13.52 ± 0.15, and 15.35 ± 0.3 years old, respectively. The results showed that Nigella sativa oil reduced the severity of all PMS symptoms except in terms of depression and abdominal bloating in IG compare to the PG. Conclusion: Nigella sativa oil in women with premenstrual syndrome can be a promising, safe, and easily available analgesic supplement.

scholarly journals Sedative and Analgesic Effects of Intravenous Midazolam and Ketamine Combination in Bone Marrow Aspiration and Biopsy of Childhood Cancer

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Seyed Mohammad Nasiraldin Tabatabaei ◽  
Ghasem Miri-Aliabad ◽  
Shahram Borjian Boroojeny ◽  
Ali Arab
Keyword(s):  
Bone Marrow ◽  
Side Effects ◽  
Bone Marrow Aspiration ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Analgesic Effects ◽  
Sedation And Analgesia ◽  
The Mean ◽  
Waking Up

Background: Various drugs, including ketamine and midazolam, are used for sedation in children. Objectives: This study aimed to evaluate the effectiveness of intravenous midazolam and ketamine combination in bone marrow aspiration and biopsy in children with cancer. Methods: This descriptive cross-sectional study was conducted on 100 children aged six months to 17 years candidates for bone marrow aspiration or biopsy. Sampling was easy, accessible, and sequential. Children were injected with 0.05 mg/kg midazolam and 1 mg/kg ketamine for sedation and analgesia. Then, sedation rate, restlessness, nausea, vomiting, laryngospasm, and decreased oxygen saturation were assessed. Data were analyzed using SPSS version 18 software. Results: The mean age of children was 6.8 ± 4.3 years. The mean degree of sedation based on the modified Ramsey score was 5.2 ± 0.74. Nausea and vomiting were observed in nine (9%) children. Six (6%) children had arterial saturation of less than 90%. Twelve (12%) children showed restlessness when waking up. There were no cases of laryngeal spasms. Conclusions: The present study showed that the intravenous midazolam and ketamine combination provides suitable sedation and analgesia to children, with low and negligible side effects.

scholarly journals Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Su Won Lee ◽  
Yee Ran Lyu ◽  
Si Yeon Kim ◽  
Won Kyung Yang ◽  
Seung Hyung Kim ◽  
...  
Keyword(s):  
Placebo Group ◽  
Standard Dose ◽  
Acute Bronchitis ◽  
Multicenter Trial ◽  
High Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
The Mean ◽  
Mean Differences

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study.Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

Oral budenosid is highly effective in the treatment of collagenous colitis: A randomized, double-blind, placebo-controlled, multicenter trial

2001 ◽  
Vol 120 (5) ◽  
pp. A40-A40 ◽  
Author(s):  
S MIEHLKE ◽  
P HEYMER ◽  
T OCHSENKUEHN ◽  
E BAESTLEIN ◽  
G YARIAN ◽  
...  
Keyword(s):  
Collagenous Colitis ◽  
Multicenter Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Highly Effective

The Antiaggressive Action of Combined Haloperidol-Propranolol Treatment in Schizophrenia

2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  
Keyword(s):  
Rating Scales ◽  
Double Blind ◽  
Propranolol Group ◽  
Schizophrenic Patients ◽  
Propranolol Treatment ◽  
Simultaneous Decrease ◽  
The Mean ◽  
Haloperidol Treatment ◽  
To Receive ◽  
Drug Free

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.

The Effect of Desmopressin on Reducing Blood Loss in Cardiac Surgery – A Meta-Analysis of Double-Blind, Placebo-Controlled Trials

1995 ◽  
Vol 74 (04) ◽  
pp. 1064-1070 ◽  
Author(s):  
Marco Cattaneo ◽  
Alan S Harris ◽  
Ulf Strömberg ◽  
Pier Mannuccio Mannucci
Keyword(s):  
Cardiac Surgery ◽  
Blood Loss ◽  
Meta Analysis ◽  
Postoperative Blood Loss ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Transfusion Requirements ◽  
The Mean ◽  
Excessive Blood Loss

SummaryThe effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials, with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (>1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.

Pharmacokinetics and Tolerability of Factor XIII Concentrates Prepared from Human Placenta or Plasma: a Crossover Randomised Study

1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  
Keyword(s):  
Factor Xiii ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomised Study ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study ◽  
Fxiii Activity ◽  
Observation Period

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

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