Analgesic Efficacy of Intravenous Paracetamol Plus Tramadol Combination for Pain after Laparoscopic Cholecystectomy: A Double-Blind, Randomized, Placebo-Controlled Trial

2014 ◽  
Vol 03 (03) ◽  
Author(s):  
Khaled El Radaideh Alaa Alhowary
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Double Blind ◽  
Intravenous Paracetamol

SP1.2.9To Evaluate the Analgesic Efficacy of Intraperitoneal Tramadol Vs Placebo for Post Operative Pain Relief Following Laparoscopic Cholecystectomy, A Double Blind Randomized Control Trial

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Siddhartha Handa ◽  
MS Sangolli ◽  
Sanjay Panchal
Keyword(s):  
Adverse Effect ◽  
Laparoscopic Cholecystectomy ◽  
Pain Relief ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Double Blind ◽  
Institutional Ethics ◽  
Intraperitoneal Instillation ◽  
The Mean

Abstract Aim To study the effectiveness of intraperitoneal instillation of tramadol for postoperative laparoscopic cholecystectomy (LC) pain relief and improve incidence of adverse effect. Methods Double blinded randomized controlled trial over 1 year. The Ethical Clearance was obtained from Institutional Ethics Committee. 60 patients scheduled for LC were enrolled in the study. Patients were randomly assigned into 2 groups using computer generated random numbers. Group T: Received intraperitoneal tramadol 100 mg (diluted in 20 mls distilled water). Group S: Received 20 ml of intraperitoneal normal saline. Pain was assessed using VAS. The assessment was done at 0, 15, 30, 60 minutes, 4, 8, 12, 16 and 24 hours. Incidence of adverse effect were observed. Results In group T, the mean pain scores at all the intervals were significantly low (p < 0.050) except at 24 hours (p = 0.210). Analgesia requirement was significantly high in group S compared to group T immediate post op, 15, 60 minutes, 8 and 12 hours (p < 0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 and 8 hours was significantly low in group T compared to group S (p < 0.050). 30% patients in group T did not require analgesia at all compared to S (p < 0.001). Incidence of adverse effects at 4 hours was 43% in group S compared to 40% in group T (p > 0.050). Conclusion Intraperitoneal instillation of tramadol in LC has beneficial effect in terms of postoperative pain relief following LC and lower requirement of analgesia. However, the incidence of adverse effects was comparable in both the groups.

scholarly journals Peritoneal Nebulization of Ropivacaine during Laparoscopic Cholecystectomy: Dose Finding and Pharmacokinetic Study

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Massimo Allegri ◽  
Martina Ornaghi ◽  
Catherine E. Ferland ◽  
Dario Bugada ◽  
Yash Meghani ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
High Performance ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Analgesic Efficacy ◽  
Postoperative Nausea And Vomiting ◽  
Dose Finding ◽  
Morphine Consumption ◽  
Double Blind ◽  
Postoperative Morphine

Background. Intraperitoneal nebulization of ropivacaine reduces postoperative pain and morphine consumption after laparoscopic surgery. The aim of this multicenter double-blind randomized controlled trial was to assess the efficacy of different doses and dose-related absorption of ropivacaine when nebulized in the peritoneal cavity during laparoscopic cholecystectomy. Methods. Patients were randomized to receive 50, 100, or 150 mg of ropivacaine 1% by peritoneal nebulization through a nebulizer. Morphine consumption, pain intensity in the abdomen, wound and shoulder, time to unassisted ambulation, discharge time, and adverse effects were collected during the first 48 hours after surgery. The pharmacokinetics of ropivacaine was evaluated using high performance liquid chromatography. Results. Nebulization of 50 mg of ropivacaine had the same effect of 100 or 150 mg in terms of postoperative morphine consumption, shoulder pain, postoperative nausea and vomiting, activity resumption, and hospital discharge timing (>0.05). Plasma concentrations did not reach toxic levels in any patient, and no significant differences were observed between groups (P>0.05). Conclusions. There is no enhancement in analgesic efficacy with higher doses of nebulized ropivacaine during laparoscopic cholecystectomy. When administered with a microvibration-based aerosol humidification system, the pharmacokinetics of ropivacaine is constant and maintains an adequate safety profile for each dosage tested.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

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

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial

2019 ◽  
Vol 36 (3) ◽  
pp. 142-147 ◽  
Author(s):  
Michelle Seiler ◽  
Georg Staubli ◽  
Markus A. Landolt
Keyword(s):  
Nitrous Oxide ◽  
Adverse Events ◽  
Scale Score ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Pain Scale ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Group ◽  
Registration Number

ObjectiveNitrous oxide 70% (N2O 70%) is an excellent medication for procedural analgosedation (PAS), yet the limit of its analgesic power remains uncertain; therefore, a combination with intranasal fentanyl (INF) was suggested. However, this combination seems to result in a higher rate of vomiting and deeper sedation. This study aimed at assessing the analgesic efficacy, sedation depth and rate of adverse events of PAS with N2O 70% with and without INF.MethodsPatients aged 2–16 years who qualified for PAS with N2O 70% were randomly assigned to receive either INF or placebo prior to N2O inhalation in this randomised, double-blind study, which was performed in a tertiary children’s hospital ED between September 2015 and October 2017. Behaviour during the procedure was evaluated using the Face, Leg, Activity, Cry and Consolability (FLACC) scale and the Modified Behavioural Pain Scale (MBPS); analgesic efficacy was assessed with a self-reported pain scale. Sedation depth using the validated University of Michigan Sedation Scale and adverse events in the ED and during the following 12 hours were documented.ResultsA total of 402 patients were included; 3 did not tolerate N2O and therefore had to be excluded. Overall, 399 patients were analysed, of whom 201 (50.4%) received INF. No significant group differences with regard to FLACC scale score, self-reported pain, MBPS score and sedation depth were found. In addition, the two groups did not differ with regard to all types of adverse events.ConclusionCombining N2O 70% with INF resulted in no differences with regard to FLACC scale score, self-reported pain, MBPS score, patient and parental satisfaction rate, sedation depth, and adverse events.Trial registration numberNCT02533908

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