Pain Assessment of Subcutaneous Injections

1996 ◽  
Vol 30 (7-8) ◽  
pp. 729-732 ◽  
Author(s):  
Jan T Jørgensen ◽  
Janne Rømsing ◽  
Mette Rasmussen ◽  
Jørn Møller-Sonnergaard ◽  
Lisbeth Vang ◽  
...  
Keyword(s):  
Pain Score ◽  
Pain Assessment ◽  
Rating Scale ◽  
Subcutaneous Administration ◽  
Injection Pain ◽  
Analog Scale ◽  
Double Blind ◽  
Subcutaneous Injections ◽  
Injection Volume ◽  
Significant Difference

OBJECTIVE: To compare injection pain after subcutaneous administration of four different solution volumes. DESIGN: Double-blind, randomized, prospective, multiple crossover study. SETTING: Steno Diabetes Centre, Gentofte, Denmark. PARTICIPANTS: Eighteen healthy volunteers, 9 women and 9 men, aged 21-30 years. METHODS: The subjects were injected with four different volumes (0.2, 0.5, 1.0, 1.5 mL) of NaCl 0.9%. The study was performed on 2 days with a 1-week washout period between the study days. On each study day the subjects received four injections in each thigh. To evaluate the validity of our pain assessing model the subjects received eight injections of 0.5 mL on one of the study days. Pain assessment was done immediately after each injection using both a 10-cm visual analog scale (VAS) and a six-item verbal rating scale (VRS). RESULTS: A significant difference in pain score on both the VAS (p < 0.05) and the VRS (p < 0.01) was seen between the four injection volumes. The pain was significantly increased with volumes of 1.0 and 1.5 mL. No significant difference in injection pain could be detected between 0.2 and 0.5 mL and between 1.0 and 1.5 mL. No significant period or carryover effect could be detected in the study. A significant correlation between the pain score on the VAS and the pain score on the VRS was found (r = 0.79, p < 0.0001). CONCLUSIONS: The pain of a subcutaneous injection is related to injection volume in the thigh. The results show that increasing the volume from 0.5 to 1.0 mL increases the pain significantly. The findings from this study should be considered when injection preparations for subcutaneous administration are formulated. The volume should generally be less than 1.0 mL if injected into the thigh.

The 5-HT1-Like Agonist Sumatriptan has a Significant Effect in Chronic Tension-Type Headache

Cephalalgia ◽  
1992 ◽  
Vol 12 (6) ◽  
pp. 375-379 ◽  
Author(s):  
Jannick Brennum ◽  
Michel Kjeldsen ◽  
Jes Olesen
Keyword(s):  
Rating Scale ◽  
Tension Type Headache ◽  
Analog Scale ◽  
Double Blind ◽  
Chronic Tension Type Headache ◽  
Significant Difference ◽  
Headache Relief ◽  
Type Headache ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Subcutaneous treatment of chronic tension-type headache with 2 mg and 4 mg sumatriptan, a selective 5-hydroxytryptamine1-like receptor agonist, was compared with placebo in a double-blind crossover study of 36 patients. The effect was evaluated using a 6-point verbal relief rating scale and by visual analog scale ratings of headache intensity before and for 2 h after treatment. Sumatriptan induced a modest but significantly greater headache relief than placebo, whereas no significant difference was found between the two doses of sumatriptan. Headache relief following sumatriptan was significant after 60 min and still seemed to be increasing after 120 min when the examination terminated. Three possible mechanisms of action of sumatriptan in tension-type headache are discussed.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

2019 ◽  
Vol 8 (5) ◽  
pp. 1067
Author(s):  
Mallikarjuna Rao I. ◽  
Usha Kiran Prayaga ◽  
Dharma Rao Uppada ◽  
Ramachandra Rao E. ◽  
B. L. Kudagi
Keyword(s):  
Depressive Disorders ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Study ◽  
P Value ◽  
Chi Square ◽  
Double Blind ◽  
Increased Risk ◽  
Significant Difference ◽  
Chi Square Test

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

scholarly journals A comparison of pain registration by Visual Analog Scale and Numeric Rating Scale – a cross-sectional study of primary triage registration

2020 ◽  
Author(s):  
Jofrid Kollltveit ◽  
Malin Osaland ◽  
Marianne Reimers ◽  
Magnus Berle
Keyword(s):  
Emergency Department ◽  
Visual Analog Scale ◽  
Rating Scale ◽  
Emergency Admission ◽  
Numeric Rating Scale ◽  
University Hospital ◽  
Analog Scale ◽  
Cross Sectional ◽  
Significant Difference ◽  
Numeric Rating

BackgroundPain is a subjective sensation; self-reporting is important for quantifying pain intensity. There are several different validated tools for this, such as Visual Analog Scale and Numeric Rating Scale. In the clinic, these terms are often used as equivalent. The objective of this study was to examine correlation and agreement between the pain registration tools in triage in an emergency department.Materials and MethodsThe study was performed in the Department of Emergency Medicine at Haukeland University Hospital in the period June-August 2019. We registered the pain score with two tools in 200 unselected patients in emergency admission with pain. In addition, we registrered gender, age, triage and general department affiliation.ResultsWe found a strong correlation between the pain registration tools by Spearmans correlation test (rho=0,930, p<0,001). There were no significant difference between the pain registration tools within the subgroups. Bland-Altman analysis show agreement between the two pain registration tools.ConclusionsIn an Emergency Department triage is it acceptable to use Visual Analog Scale and Numeric Rating Scale as equivalent, as long as the correct terminology is used.

scholarly journals Intravenous Paracetamol vs Intranasal Desmopressin for Renal Colic in the Emergency Department: A Randomized Clinical Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3437-3442
Author(s):  
Hamed Basir Ghafouri ◽  
Niloofar Abazarian ◽  
Mohammadreza Yasinzadeh ◽  
Ehsan Modirian
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Pain Score ◽  
Randomized Clinical Trial ◽  
Renal Colic ◽  
Rating Scale ◽  
Pain Scores ◽  
Intravenous Paracetamol ◽  
Significant Difference ◽  
Intranasal Desmopressin

Abstract Objective To evaluate the analgesic efficacy of intranasal desmopressin alone vs intravenous paracetamol in patients referred to the emergency department with renal colic. Design Randomized clinical trial. Setting This study was conducted in the emergency unit of a university hospital. Subjects Patients referred to the emergency room with renal colic. Primary Outcome Effect of intranasal desmopressin in pain relief in comparison with intravenous paracetamol. Methods In this trial, 240 patients diagnosed with renal colic were randomly divided into two groups to compare the analgesic effect of intravenous paracetamol (15 mg/kg) and intranasal desmopressin spray (40 μg). Pain scores were measured by a numeric rating scale at baseline and after 15, 30, and 60 minutes. Adverse effects and need for rescue analgesic (0.05 mg/kg max 3 mg morphine sulphate) were also recorded at the end of the study. Results Three hundred patients were eligible for the study; however, 240 were included in the final analysis. The patients in the two groups were similar in their baseline characteristics and baseline pain scores. The mean pain score after 15 minutes was more reduced and was clinically significant (&gt;3) in the desmopressin group (P &lt; 0.0001). There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (&gt;6). Conclusions Our study showed that intranasal desmopressin is as effective as intravenous paracetamol for renal colic pain management; however, significant clinical reduction in pain score occurred faster with intranasal desmopressin.

scholarly journals A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia

Pain Medicine ◽  
2019 ◽  
Vol 21 (2) ◽  
pp. 326-332 ◽  
Author(s):  
Hiroshi Oka ◽  
Kenji Miki ◽  
Iwao Kishita ◽  
David F Kong ◽  
Takahiro Uchida
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Repeated Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Double Blind ◽  
Point Change ◽  
Entire Treatment Period ◽  
Magnetic Field Therapy ◽  
Significant Difference

Abstract Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

A Controlled Comparative Trial of a New Antidepressant, Ciclazindol

1979 ◽  
Vol 7 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Sidney Levine
Keyword(s):  
Rating Scale ◽  
Comparative Trial ◽  
Poor Response ◽  
Endogenous Depression ◽  
Depressive Illness ◽  
Double Blind ◽  
Significant Difference ◽  
Severity Of Depression ◽  
The Mean ◽  
Rate Of Response

The author describes a controlled, double-blind, comparative trial of a new tetracyclic compound, ciclazindol (WY 23409), against amitriptyline in the treatment of thirty-five patients admitted to hospital with depressive illness. Each patient was randomly allocated to three weeks treatment with either 50 mg b.d. ciclazindol or 50 mg b.d. amitriptyline. In the event of a poor response the dose level was raised to 75 mg b.d. Separation of cases of endogenous depression and severity of depression were assessed by the Levine-Pilowsky Depression Questionnaire, a self-rating technique. Severity of depression was also assessed using the Hamilton Rating Scale. No significant difference was noted between the drugs in either the degree or the rate of response nor when the endogenous cases alone were studied. The interesting observation was made that only one-third of ciclazindol patients gained weight compared to almost three-quarters of the amitriptyline group and the mean weight gain of the latter was over double that of the ciclazindol group. The author concludes that ciclazindol offers promise and merits further study using higher dosage levels once its full safety trials have been completed.

Comparison of efficacy between risperidone and aripiprazole in combination with sodium valproate in patients with acute manic or mixed episodes

2017 ◽  
Vol 41 (S1) ◽  
pp. S749-S749
Author(s):  
N. Amanat ◽  
A. Nazeri Astane ◽  
B. Dieji ◽  
O. Rezaie ◽  
A. Biglarian
Keyword(s):  
Weight Gain ◽  
Sodium Valproate ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Young Mania ◽  
Double Blind ◽  
Measurement Evaluation ◽  
Significant Difference ◽  
Competing Interest ◽  
Bipolar Patients

Today, despite of the improvement in the psychological therapeutic approach, mania still remains as a challenging problem for health system. The aim of this study is comparison efficacy of risperidone and aripiprazole in combination with sodium valproate in bipolar patients with acute manic or mixed episodes who hospitalized in Razi psychiatric hospital in Tehran. This study was conducted as a double blind randomized clinical trial in two groups of bipolar disorder patients with manic or mixed episodes (18–65 age). Patients randomly set in two groups who received valproate with aripiprazole or risperidone. Clinical response was assessed with young mania rating scale (YMRS) and weight gain at 3 and 6 weeks. Data was analyzed with Chi2 test, paired t-test and analysis of covariance and repeated measurement. Evaluation of treatment response after 3 and 6 weeks (50% reduction in Young's scale) in both groups did not show any significant difference between the two therapeutic combinations. The combination of sodium valproate and risperidone showed higher weight gain in comparison with the combination of valproate and aripiprazole at the end of week 6 (P < 0.001). The mentioned combination in bipolar I disorder with manic or mixed episode has similar therapeutic effect, so that both of them are effective and usable. There was no difference in their efficacy, and both treatments can be used. Due to the less weight gain, the combination of valproate and aripiprazole in patients who prone to weight gain, this approach is recommended as more safe and effective therapy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Sexual Function during Bupropion or Paroxetine Treatment of Major Depressive Disorder

2006 ◽  
Vol 51 (4) ◽  
pp. 234-242 ◽  
Author(s):  
Sidney H Kennedy ◽  
Kari A Fulton ◽  
R Michael Bagby ◽  
Andrea L Greene ◽  
Nicole L Cohen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sexual Function ◽  
Rating Scale ◽  
Primary Objective ◽  
Major Depressive ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Over Time

Objective: The primary objective was to evaluate sexual function (SF) separately in men and women with major depressive disorder (MDD) before and during treatment with bupropion sustained release (SR) or paroxetine. The secondary objectives involved a comparative evaluation of the Sex Effects Scale (Sex FX) and the Investigator-Rated Sexual Desire and Functioning Scale (IRSD-F), as well as a comparison of antidepressant outcomes and an examination of the relation between level of depression and SF over time. Method: There were 141 patients (68 women and 73 men) who met DSM-IV criteria for a current major depressive episode. They were randomly assigned to receive bupropion SR (150 to 300 mg daily) or paroxetine (20 to 40 mg daily) under double-blind trial conditions. Patients were assessed at baseline and at 2, 4, 6, and 8 weeks with the 17-item Hamilton Depression Rating Scale (HDRS17), Sex FX, and IRSD-F. Results: Prior to treatment, women reported significantly lower SF on both the Sex FX and IRSD-F scales, compared with men. During treatment, there were no significant drug differences on measures of SF over time for women; however, men who were treated with paroxetine reported a worsening of SF, whereas bupropion SR did not significantly alter SF. Both bupropion SR and paroxetine produced clinically and statistically significant reductions in HDRS17 scores as well as comparable rates of response and remission. There was a statistically significant correlation between the 2 measures of SF at all visits. There was also a significant inverse relation between depression and SF in women, but not in men, irrespective of drug. Conclusion: According to the Sex FX scale, a significant difference in antidepressant-related sexual dysfunction was detected in men, but not women, during treatment with bupropion SR or paroxetine.

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.

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