A Comparison of xylometazoline (Otrivine) and phenylephrine/lignocaine mixture (Cophenylcaine) for the purposes of rigid nasendoscopy: a prospective, double-blind, randomised trial

AbstractObjective:To evaluate if phenylephrine–lignocaine mixture (Cophenylcaine) nasal spray performs better than xylometazoline (Otrivine) spray for the purposes of out-patient rigid nasendoscopy preparation.Design:Prospective, double-blind, randomised trial comparing visual analogue scores for out-patients receiving either phenylephrine–lignocaine mixture or xylometazoline, prior to undergoing rigid nasendoscopy as part of their assessment.Subjects:Seventy-three patients requiring rigid nasendoscopy as part of their assessment were recruited to the study from Raigmore Hospital's out-patient clinic. These patients were randomised to receive a nasal spray comprising either phenylephrine–lignocaine mixture or xylometazoline, 10 minutes prior to rigid nasendoscopy. Double-blinding was adopted. After the procedure, the patient and the doctor independently completed separate visual analogue score-based questionnaires regarding the pain of the procedure and the ease of the examination, respectively.Results:Analysis of the data using standardised statistical methods demonstrated that the phenylephrine–lignocaine mixture did not perform better than xylometazoline, to any statistically significant extent.Conclusion:Phenylephrine–lignocaine mixture is considerably more expensive and has potentially more side effects than xylometazoline. These study findings suggest that it is difficult to justify the use of phenylephrine–lignocaine mixture over xylometazoline, for nasal preparation prior to rigid nasendoscopy.

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High-Dose Adrenaline in Adult In-Hospital Asystolic Cardiopulmonary Resuscitation: A Double-Blind Randomised Trial

Anaesthesia and Intensive Care ◽

10.1177/0310057x9302100210 ◽

1993 ◽

Vol 21 (2) ◽

pp. 192-196 ◽

Cited By ~ 38

Author(s):

J. Lipman ◽

W. Wilson ◽

S. Kobilski ◽

J. Scribante ◽

C. Lee ◽

...

Keyword(s):

Intensive Care Unit ◽

Cardiac Arrest ◽

Intensive Care ◽

Side Effects ◽

Cardiopulmonary Resuscitation ◽

Standard Dose ◽

Randomised Trial ◽

High Dose ◽

Double Blind ◽

To Receive

Forty intensive care unit patients requiring cardiopulmonary resuscitation were randomised to receive either the standard dose of adrenaline (1 mg every five minutes) or high-dose adrenaline (10 mg every five minutes). In the majority of patients, overwhelming sepsis was the major contributing factor leading to cardiac arrest. In this group of patients no difference could be detected in response to high-dose adrenaline compared with the standard dose. Although no side-effects were noted with this high dose of adrenaline, more investigation is required prior to its routine use in cardiopulmonary resuscitation.

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Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

10.1101/2021.04.13.21255409 ◽

2021 ◽

Author(s):

Juan Manuel Figueroa ◽

Monica Lombardo ◽

Ariel Dogliotti ◽

Luis Flynn ◽

Robert P. Giugliano ◽

...

Keyword(s):

Placebo Group ◽

Nasal Spray ◽

Controlled Trial ◽

Hospital Personnel ◽

Culture Methods ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Efficacy ◽

To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

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Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone.

Journal of Clinical Oncology ◽

10.1200/jco.1991.9.4.675 ◽

1991 ◽

Vol 9 (4) ◽

pp. 675-678 ◽

Cited By ~ 193

Author(s):

F Roila ◽

M Tonato ◽

F Cognetti ◽

E Cortesi ◽

G Favalli ◽

...

Keyword(s):

Side Effects ◽

Crossover Study ◽

Receptor Antagonist ◽

Treatment Preference ◽

Complete Protection ◽

Double Blind ◽

Significant Difference ◽

Antiemetic Activity ◽

To Receive ◽

Randomized Crossover Study

Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses greater than or equal to 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P less than .003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.

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Efficacy of Nimodipine in the Prophylaxis of Migraine

Cephalalgia ◽

10.1046/j.1468-2982.1985.0501039.x ◽

1985 ◽

Vol 5 (1) ◽

pp. 39-43 ◽

Cited By ~ 31

Author(s):

H Havanka-Kanniainen ◽

E Hokkanen ◽

VV Myllylä

Keyword(s):

Side Effects ◽

Drug Treatment ◽

Double Blind ◽

Double Blind Placebo ◽

Final Value ◽

Prophylactic Drug ◽

Better Than

The efficacy of nimodipine in the prophylaxis of migraine was assessed in a double-blind, placebo-controlled, cross-over study carried out on 33 patients, 20 of whom suffered from classic and 13 from common migraine. Four patients dropped out, but not as a result of the side effects of the drug. The duration of drug treatment was 8 weeks. The dosage used was 30 mg four times daily. Nimodipine proved to be better than placebo, the number of migraine attacks and severity of headache showing a significant reduction. The drug was well tolerated and no marked side effects were noted. The results suggest that nimodipine is a useful new prophylactic drug for migraine, but further studies are needed before its final value can be evaluated.

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A Controlled Trial of Baclofen in Children with Cerebral Palsy

Journal of International Medical Research ◽

10.1177/030006057300100203 ◽

1973 ◽

Vol 1 (2) ◽

pp. 398-404 ◽

Cited By ~ 3

Author(s):

P J Milla ◽

A D M Jackson

Keyword(s):

Cerebral Palsy ◽

Side Effects ◽

Dose Reduction ◽

Crossover Trial ◽

Controlled Trial ◽

Drug Effects ◽

Double Blind ◽

Muscle Spasticity ◽

Children With Cerebral Palsy ◽

Better Than

A double-blind crossover trial against placebo was conducted to assess the effects of the GABA derivative, baclofen, on the disabilities due to muscle spasticity in twenty children suffering from cerebral palsy. Baclofen performed very significantly better than placebo in reducing spasticity and significantly better than placebo in allowing both active and passive limb movements to be carried out. Notable improvement was also seen in scissoring. Side-effects were minimal and responded promptly to dose reduction. The evaluation of drug effects on muscle spasticity and the pharmacodynamics of baclofen are discussed. Recommendations are made regarding dosage of baclofen in childhood.

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Intraoperative and Postoperative Analgesia Using Intravenous Opioid, Clonidine and Lignocaine

Anaesthesia and Intensive Care ◽

10.1177/0310057x9402200103 ◽

1994 ◽

Vol 22 (1) ◽

pp. 15-21 ◽

Cited By ~ 31

Author(s):

M. de Kock ◽

P. Lavandhomme ◽

J. L. Scholtes

Keyword(s):

Side Effects ◽

Postoperative Analgesia ◽

Randomised Trial ◽

Skin Incision ◽

Time Interval ◽

Colonic Surgery ◽

Double Blind ◽

Group A ◽

Group B ◽

Group D

The postoperative analgesia afforded after colonic surgery by IV opioid, clonidine and lignocaine given intra- and postoperatively was evaluated. In a double-blind randomised trial, 80 male patients scheduled for colonic resection under general anaesthesia received fentany 15 μg.kg−1 at induction and another 4 μg.kg−1 before skin incision (group A) or fentanyl (same dose) plus clonidine 4 μg.kg−1 in 20 min + 2 μg.kg−1.h−1 (group B, C) or fentanyl plus clonidine (same dosage) plus lignocaine 2 mg.kg−1 before skin incision, repeated before peritoneal incision and retractor placement (group D). In the four groups, intraoperative boluses of fentanyl 2 μg.kg−1 were given in response to the painful stimulation of the procedure. Postoperative pain was managed with PCA delivering 2 mg morphine per request in group A, 1.5 mg morphine in group B, 1.5 mg morphine + 15 μg clonidine in group C and 1.2 mg morphine + 15 μg clonidine + 23 mg lignocaine in group D. Postoperative analgesia was assessed by recording the analgesic demands (met and unmet) and the dose of morphine delivered at 6, 12, 18, 24, 36 hours. Side-effects, pain and sedation analogue scores were also recorded. A nalgesic demands and delivered morphine dose were reduced, at any time interval considered, in groups B, C, D, compared with A (P <0.001). No differences were noted between the groups B, C, D. Pain analogue scores were better in groups B, C, D compared with group A (P <0.001). Sedation and side-effects were not increased in groups B, C, D. Intraoperative clonidine was the major determinant of the reduction in analgesic demands and morphine delivered. Lignocaine, at the dose used, failed to afford any additional benefit.

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Comparison of the efficacy of moclobemide and fluvoxamine in elderly patients with a severe depressive episode

European Psychiatry ◽

10.1017/s0924933800000705 ◽

1993 ◽

Vol 8 (6) ◽

pp. 319-324 ◽

Cited By ~ 8

Author(s):

JP Bocksberger ◽

JP Gachoud ◽

J Richard ◽

Ρ Dick

Keyword(s):

Side Effects ◽

Elderly Patients ◽

Psychomotor Retardation ◽

Antidepressant Effect ◽

Reversible Inhibitor ◽

Double Blind Study ◽

Double Blind ◽

New Class ◽

Low Incidence ◽

To Receive

SummaryIn a double-blind study carried out on elderly patients (older than 65 years) the efficacy and tolerability of the new antidepressant moclobemide was compared. Moclobemide belongs to a new class of substances called RIMA (Reversible inhibitor of the monoamine oxidase type A). Fluvoxamine, a selective reuptake-inhibitor of 5-HT, belongs to a class of antidepressants known for their better tolerability compared to tricyclic especially with elderly patients. Forty elderly patients (mean age 75 years) with major depression (according to DSM III) were randomized to receive either moclobemide (300 mg) or fluvoxamine (100 mg) twice daily. Dosages were increased when necessary on day 8, to a maximum of 450 mg moclobemide or 200 mg fluvoxamine and in most cases were maintained at these levels for the remainder of the study period (four weeks). Moclobemide was more effective than fluvoxamine showing a marked antidepressant effect and an earlier effect on psychomotor retardation. The two drugs were well tolerated showing a low incidence of side effects.

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Tolfenamic Acid, Metoclopramide, Caffeine and Their Combinations in The Treatment of Migraine Attacks

Cephalalgia ◽

10.1046/j.1468-2982.1984.0404253.x ◽

1984 ◽

Vol 4 (4) ◽

pp. 253-263 ◽

Cited By ~ 45

Author(s):

Riitta A Tokola ◽

Pentti Kangasniemi ◽

Pertti J Neuvonen ◽

Olavi Tokola

Keyword(s):

Side Effects ◽

Clinical Studies ◽

Tolfenamic Acid ◽

Acute Migraine ◽

Double Blind ◽

Better Than

Tolfenamic acid is a fenamate which inhibits prostaglandin (PG) biosynthesis and may act as a PG antagonist as well. Caffeine and metoclopramide are used in combination with analgesics and ergotamine in the treatment of migraine attacks, but controlled clinical studies on fixed combinations with analgesics are rare. The effects of orally given tolfenamic acid (200 mg), caffeine (100 mg), metoclopramide (10 mg), tolfenamic acid + caffeine (200 mg + 100 mg), tolfenamic acid + metoclopramide (200 mg + 10 mg) and placebo were studied in 49 migraine patients (3 men, 46 women) in a double-blind randomized cross-over study comprising 482 migraine attacks. The patients were allowed to take either one or two capsules of each preparation for an attack. Additional drugs were allowed after 3 h. Parameters characterizing the effects and side-effects of the drugs were registered. Tolfenamic acid and its combinations were found to be effective in the treatment of acute migraine, but caffeine and metoclopramide alone did not differ from placebo. Combination with metoclopramide was better than tolfenamic acid alone as judged by the smaller dose needed and the intensity of attack. Between tolfenamic acid alone and its caffeine combination there were no statistically significant differences.

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A double-blind, randomized cross-over trial of venlafaxine versus clonidine to treat hot flashes in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9083 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9083-9083

Author(s):

C. Mom ◽

C. Buijs ◽

P. H. Willemse ◽

H. Boezen ◽

J. Maurer ◽

...

Keyword(s):

Breast Cancer ◽

Side Effects ◽

Cancer Patients ◽

Hot Flashes ◽

Breast Cancer Patients ◽

Double Blind ◽

Hot Flash ◽

History Of ◽

Loss Of Appetite ◽

To Receive

9083 Background: Breast cancer patients who become postmenopausal due to their treatment can experience more frequent and severe hot flashes than healthy postmenopausal women. Estrogens are considered to be contra-indicated. Venlafaxine and clonidine are both used to alleviate hot flashes, with different side effects. This study compared side effects, efficacy and patient preference. Methods: In a double-blind, cross-over study women <60 years, with a history of breast cancer, and experiencing at least 14 hot flashes/week were randomized to receive venlafaxine 75 mg od (and placebo bid) for 8 weeks, followed by a 2 week wash-out period, and 8 weeks of clonidine 0.025 mg bid (and placebo od) or vice versa. Hot flash frequency and hot flash score (frequency × severity) were recorded in a diary and side effects were scored using a questionnaire during the 2nd and 8th week of both treatment periods, and these were compared to a baseline week. Results: Sixty patients were randomized to start with venlafaxine (n=30) and clonidine (n=30), 40 completed both treatment periods. Premature treatment discontinuation occurred in 15/59 patients during venlafaxine and in 5/53 during clonidine due to side effects (p<0.05). The main side effects of venlafaxine were nausea and headache, and of clonidine dry mouth. In the 8th week of treatment women reported more loss of appetite (24% vs 4%; p=0.03) and improved sleeping (55% vs 75%; p=0.03) with venlafaxine. A =50% reduction in hot flash score was found in 21 (49%) and 26 (55%) of the patients with venlafaxine and clonidine respectively (ns). The decrease in hot flash score was most marked in the first treatment period. At study completion 20 (33%) of the patients chose to continue clonidine, and 17 (29%) preferred venlafaxine (ns), whereas 23 (38%) declined further treatment. Conclusions: Venlafaxine and clonidine are both moderately and equally effective in the reduction of hot flashes. Side effects are the main reason for discontinuation, occurring more often during treatment with venlafaxine. No significant financial relationships to disclose.

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A Clinical Comparison of Triazolam with Placebo and with Secobarbital in Insomniac Patients

Journal of International Medical Research ◽

10.1177/030006057800600413 ◽

1978 ◽

Vol 6 (4) ◽

pp. 343-347 ◽

Cited By ~ 7

Author(s):

K Kay Okawa ◽

George S Allen

Keyword(s):

Side Effects ◽

Sleep Duration ◽

Sleep Onset ◽

Questionnaire Data ◽

Efficacy And Safety ◽

Double Blind ◽

Sleep Questionnaire ◽

Clinical Comparison ◽

Hypnotic Efficacy ◽

Better Than

Seventy-six out-patient insomniacs participated in three different two-night, double-blind crossover trials investigating the hypnotic efficacy and safety of triazolam. Triazolam 0.5 mg was compared to placebo in one trial conducted by K Kay Okawa, MD, and triazolam 0.5 mg was compared to secobarbital 100 mg in trials conducted by K Kay Okawa, MD and George S Allen, MD. The results of the latter two studies were combined and the data analyzed jointly. Triazolam 0.5 mg was found to be preferred and to be significantly better than both placebo and secobarbital 100 mg in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to either placebo or secobarbital on the following parameters: how much the medication helped the patient sleep; onset of sleep; duration of sleep; and number of nocturnal awakenings. No differences were observed between treatments in any trial with regard to the patient's feeling of alertness the next morning. The side-effects reported for all treatments did not significantly interfere with the patients' ability to function.

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