Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial

2020 ◽  
Vol 65 (1) ◽  
pp. 12-18
Author(s):  
Shahram Ala ◽  
Neda Zamani ◽  
Jafar Akbari ◽  
Ebrahim Salehifar ◽  
Ghasem Janbabai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Sufficient Evidence ◽  
Controlled Clinical Trial ◽  
Significant Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background and aims Gabapentin has been used for the management of radiotherapy and chemotherapy induced stomatitis in a number of studies. Due to lack of sufficient evidence, the present study was designed to evaluate the efficacy of gabapentin mouthwash in oral mucositis associated pain in patients undergoing cancer chemotherapy. Methods and results This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients were randomly divided into two groups receiving either the gabapentin or placebo mouthwash. Patients were advised to rinse their mouth with 7 ml of solution for 30 s three times a day and were visited 10 days after initiation of the trial. The intensity of pain and severity of oral mucositis were assessed. Thirty-one patients received gabapentin mouthwash while 27 patients received placebo. Both gabapentin and placebo mouthwashes had decreased the pain intensity almost equally and did not show a significant difference between the two groups (P = 0.73). Also both gabapentin and placebo had reduced and improved swallowing, inflammation and erythema. But there was no noticeable difference between groups (P > 0.05). Conclusions These findings indicate that gabapentin mouthwash did not show a significant activity as a pain relieving agent in chemotherapy induced oral mucositis associated pain.

Early analgesic effects of intravenous parecoxib and rectal diclofenac following laparoscopic sterilization: A double-blind, double-dummy randomized controlled trial

2018 ◽  
Vol 4 (1) ◽  
pp. 49
Author(s):  
Alexander Ng, MD, FRCA ◽  
Ajay Swami, FFARCSI ◽  
Graham Smith, MD, FRCA ◽  
Joe Emembolu, FRCOG
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Analgesic Effects ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Laparoscopic Sterilization ◽  
Rescue Antiemetic

The aim of this double-blind double-dummy randomized controlled trial was to investigate if there was any difference in analgesia between the maximum recommended doses of rectal diclofenac and iv parecoxib after laparoscopic sterilization. The authors studied 55 ASA I-II patients undergoing gynecological laparoscopy; each patient received either preoperative rectal diclofenac 100 mg and 2 mL of normal saline at induction of anesthesia, or preoperative placebo suppository and 2 mL of parecoxib 40 mg at induction. Pain intensity, sedation, and nausea were measured using a 100-mm visual analogue scale on awakening and at 1, 2, and 3 hour postoperatively. Median (interquartile range) pain intensity at rest on awakening and at 1, 2, and 3 hour postoperatively were 15 (0-40), 37 (10-56), 16 (6-29), and 13 (2-32) mm, respectively, in the parecoxib group, and 3 (0-34), 22 (5-45), 24 (6-37), and 10 (4-21) mm, respectively, in the diclofenac group. There was no significant difference in these scores. Furthermore, there was no significant difference between the two groups in sedation, nausea, rescue analgesia, or rescue antiemetic consumption. Preoperative rectal diclofenac 100 mg and parecoxib 40 mg iv at induction of anesthesia were found to have equianalgesic effects after laparoscopic sterilization. Both drugs appear to be useful after short anaesthetics.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

A randomized controlled trial (RCT) of 2 dose ratios for conversion from parenteral to oral methadone in patients with cancer pain.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 206-206
Author(s):  
Jesus Gonzalez-Barboteo ◽  
Josep Porta-Sales ◽  
Maria Nabal-Vicuña ◽  
Leyre Diez-Porres ◽  
Jaume Canal ◽  
...  
Keyword(s):  
Side Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Oral Route ◽  
Dose Ratio ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference ◽  
Lower Ratio

206 Background: Methadone (M) is frequently used for severe cancer pain using the parenteral and oral route. The most commonly used dose ratio (DR) parenteral: oral is 1:2. However, methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. The main objective of this RCT is to compare success and side effects with 2 ratios of parenteral to oral M: 1:2 vs 1:1.2 in hospitalized patients with cancer pain. Methods: Inpatients with cancer pain well controlled with parenteral M requiring rotation to the oral route. Double blind RCT. Outcomes included pain intensity (BPI), opioid toxicity (CTCAE), and M dose. Success was defined as good pain control with no toxicity at 72hs. Results: 39/44 randomized patients were evaluable (89%): 21 in DR 1:2 and 18 in DR 1:1.2. 71% male, median age 65. No significant difference between DR1:2 and DR1:1.2 in frequency of neuropathic pain (64 Vs 68%), Papscore A/B (100 Vs 91%), CAGE + (23 Vs 18%). Median M dose pre/post was 24.5mg±13.5 y 49 mg±27.3 for DR 1:2, Vs 23.3mg±9.4 (p: NS) y 28mg±11.3 (p < 0.01) for DR 1:1.2. The DR1:2 group developed more cumulative toxicity at dasy 1, 2 and 3 (p < 0.015, p < 0.006 y p < 0.001 respectively). Pain intensity pre/ post was: 1.58±1.3 and 0.87±1.0, ns for DR 1:2, Vs 1.13±0.7 (p:NS) and 1.07±0.9 (p:NS) for DR 1:1.2. Success was observed in 12 pts in DR1:2 Vs 18 in DR 1:1.2, p < 0.001. Side effects related to M were observed in 33/46 pts in DR 1:2 (mainly neurotoxicity symptoms) Vs 1/6 in DR 1:1.2. Conclusions: DR 1:1.2 when changing from parenteral to oral M resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during M route change should be considered. Granted by Spanish Ministry of Health EC10-133. EUDRACT Number: 2010-024092-39. Clinical trial information: 2010-024092-39.

A Comparative Study of Lactic Acid 10% and Ammonium Lactate 12% Lotion in the Treatment of Foot Xerosis

2002 ◽  
Vol 92 (3) ◽  
pp. 143-148 ◽  
Author(s):  
Maureen B. Jennings ◽  
Loretta Logan ◽  
Donna M. Alfieri ◽  
Charles F. Ross ◽  
Susan Goodwin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
New York ◽  
Lactic Acid ◽  
Comparative Study ◽  
Clinical Assessment ◽  
Double Blind ◽  
Treatment Groups ◽  
Baseline Visit ◽  
Ammonium Lactate ◽  
Significant Difference

Xerotic skin is a pattern of reaction to a variety of disorders that have abnormalities of desquamation in common. This double-blind, randomized clinical trial investigated the effect of Lactinol (Pedinol Pharmaceuticals, Farmingdale, New York) versus Lac-Hydrin 12% (Bristol-Myers Squibb, Princeton, New Jersey) lotion in mild to moderate foot xerosis. Clinical assessment of xerosis was performed at baseline visit, and the designated sites were evaluated at 2 and 4 weeks after treatment began. Of the 53 patients enrolled, 18 were excluded from analysis. Although both treatment groups had significantly improved xerosis scores after 2 and 4 weeks of treatment, no statistically significant difference was observed. Of the 44% of patients who did express a preference, 72% preferred Lactinol, which may account for the 20% increase in its overall use in the study. (J Am Podiatr Med Assoc 92(3): 143-148, 2002)

scholarly journals Exploratory Randomized Double-Blind Placebo-Controlled Trial of Botulinum Therapy on Grasp Release After Stroke (PrOMBiS)

2019 ◽  
Vol 34 (1) ◽  
pp. 51-60
Author(s):  
Amanda Claire Wallace ◽  
Penelope Talelli ◽  
Lucinda Crook ◽  
Duncan Austin ◽  
Rachel Farrell ◽  
...  
Keyword(s):  
Upper Limb ◽  
Goal Attainment ◽  
Controlled Trial ◽  
Release Time ◽  
Single Treatment ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Arm Function ◽  
Goal Attainment Scale

Background. OnabotulinumtoxinA injections improve upper-limb spasticity after stroke, but their effect on arm function remains uncertain. Objective. To determine whether a single treatment with onabotulinumtoxinA injections combined with upper-limb physiotherapy improves grasp release compared with physiotherapy alone after stroke. Methods. A total of 28 patients, at least 1 month poststroke, were randomized to receive either onabotulinumtoxinA or placebo injections to the affected upper limb followed by standardized upper-limb physiotherapy (10 sessions over 4 weeks). The primary outcome was time to release grasp during a functionally relevant standardized task. Secondary outcomes included measures of wrist and finger spasticity and strength using a customized servomotor, clinical assessments of stiffness (modified Ashworth Scale), arm function (Action Research Arm Test [ARAT], Nine Hole Peg Test), arm use (Arm Measure of Activity), Goal Attainment Scale, and quality of life (EQ5D). Results. There was no significant difference between treatment groups in grasp release time 5 weeks post injection (placebo median = 3.0 s, treatment median = 2.0 s; t(24) = 1.20; P = .24; treatment effect = −0.44, 95% CI = −1.19 to 0.31). None of the secondary measures passed significance after correcting for multiple comparisons. Both groups achieved their treatment goals (placebo = 65%; treatment = 71%), and made improvements on the ARAT (placebo +3, treatment +5) and in active wrist extension (placebo +9°, treatment +11°). Conclusions. In this group of stroke patients with mild to moderate spastic hemiparesis, a single treatment with onabotulinumtoxinA did not augment the improvements seen in grasp release time after a standardized upper-limb physiotherapy program.

Continuation therapy with lithium and amitriptyline in unipolar depressive illness: a randomized, double-blind, controlled trial

1984 ◽  
Vol 14 (1) ◽  
pp. 37-50 ◽  
Author(s):  
A. I. M. Glen ◽  
A. L. Johnson ◽  
M. Shepherd
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Detailed Analysis ◽  
Controlled Trial ◽  
Depressive Illness ◽  
Double Blind ◽  
Prophylactic Efficacy ◽  
Continuation Therapy ◽  
Significant Difference ◽  
Clinically Significant

SynopsisA detailed analysis of the results of a multi-centre clinical trial shows that, while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo, there was no clinically significant difference between the prophylactic efficacy of the 2 antidepressants. An account is given of the relative adverse effects of the treatments, and the implications of the findings are discussed.

scholarly journals Double-blind, crossover, placebo-controlled clinical trial with clobetasol propionate in desquamative gingivitis

2009 ◽  
Vol 20 (3) ◽  
pp. 231-236 ◽  
Author(s):  
Ana Carolina Fragoso Motta ◽  
Carina Domaneschi ◽  
Marilena Chinali Komesu ◽  
Cacilda da Silva Souza ◽  
Valéria Aoki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Clobetasol Propionate ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Significant Difference

The aim of this study was to evaluate the efficacy of a 0.05% clobetasol propionate ointment administered in trays to 22 patients with desquamative gingivitis in a double-blind, crossover, placebo-controlled trial. Patients received container number 1 and were instructed to apply the ointment 3 times a day for 2 weeks, and to reduce the application to once a day in the third week. Next, the patients were then instructed to discontinue the treatment for 2 weeks, and were then given container 2, used in the same way and for the same length of time as container 1. Regarding signs, 17 patients presented some improvement, while 5 experienced worsening with clobetasol propionate. With the placebo, 14 patients presented some improvement, and 8 patients presented worsening. For symptoms, there was complete improvement in 2 patients, partial improvement in 12, no response in 7, and worsening in 1 with clobetasol propionate. With the placebo, there was partial improvement in 8 patients, no response in 12 and worsening in 2. No statistically significant difference was found between clobetasol and placebo (p>0.05). Within the period designed to treat the gingival lesions of the patients, clobetasol propionate did not significantly outperform the placebo.

Homeopathic treatment of migraine: A double blind, placebo controlled trial of 68 patients

2000 ◽  
Vol 89 (01) ◽  
pp. 4-7 ◽  
Author(s):  
P Straumsheim ◽  
C Borchgrevink ◽  
P Mowinckel ◽  
H Kierulf ◽  
O Hafslund
Keyword(s):  
Pain Intensity ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Homeopathic Treatment ◽  
Registration Period ◽  
Significant Difference ◽  
Accompanying Symptoms

AbstractTo evaluate the efficacy of homeopathy in preventing migraine attacks and accompanying symptoms, a randomised, double-blind, placebo-controlled clinical trial was conducted. There was a one-month registration period without treatment, followed by four months individualised homeopathic treatment or identical placebo. Patients were stratified for common or classical migraine.Seventy-three patients were randomised, 68 completed the trial. Baseline values were similar in the two groups. Both the homeopathy and placebo groups had reduction in attack frequency, pain intensity and drug consumption, with a statistically non-significant difference favouring homeopathy. Migraine diaries showed no difference between groups. The neurologists’ trial evaluation showed a statistically significant reduction in attack frequency in the homeopathy group (P=0.04) and non-statistically significant trends in favour of homeopathy for pain intensity and overall evaluation.Further research, with improved trial design, on the possible role of homeopathy in migraine prophylaxis is justified.

scholarly journals Effectiveness of Levodropropizine on Post-Operative Sore Throat After Endotracheal Intubation for Head and Neck Surgery: A Double-Blind Randomized Controlled Trial

2020 ◽  
Vol 35 (2) ◽  
pp. 6
Author(s):  
Ivabelle Ducto ◽  
Joseph Cachuela
Keyword(s):  
Head And Neck ◽  
Sore Throat ◽  
Medical Center ◽  
Controlled Trial ◽  
Neck Surgery ◽  
Orotracheal Intubation ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference

ABSTRACT Objective: To determine the effectiveness of levodropropizine in reducing the incidence of post-operative sore throat (POST) among ear, nose, throat, head and neck (ENT-HNS) patients undergoing general endotracheal anesthesia. Methods:Design: Double-Blind, Randomized, Placebo Controlled TrialSetting: Tertiary Government Training Hospital Participants: Sixty (60) ENT-HNS patients aged between 19 to 60 years old admitted to the Southern Philippines Medical Center from January to March 2019 for surgeries on benign thyroid tumors, benign submandibular gland tumors and tonsils requiring orotracheal intubation were randomized into control and treatment groups of 30 patients each. Results: There was a statistically significant difference (p=.0016) in the incidence of POST 6 hours after surgery between control (25/30; 83%) and treatment (16/30; 53.33%) groups. However, confounders such as length and type of surgery (more females and tonsillectomy cases in the control group) were not fully eliminated by randomization. Conclusion: Perioperative levodropropizine significantly decreases the incidence of moderate (as well as mild) postoperative sore throat. It was not shown to decrease the incidence of severe sore throat. A larger cohort (adjusted for other confounders) may better describe the benefit of this treatment.

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