A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor

2003 ◽  
Vol 188 (4) ◽  
pp. 1046-1051 ◽  
Author(s):  
Robert J. Sawdy ◽  
Shiromi Lye ◽  
Nicholas M. Fisk ◽  
Phillip R. Bennett
Keyword(s):  
Side Effects ◽  
Preterm Labor ◽  
Randomized Study ◽  
Short Term ◽  
Double Blind ◽  
Maternal Administration

scholarly journals Spontaneous improvement of carbohydrate-deficient transferrin in PMM2-CDG without mannose observed in CDG natural history study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Peter Witters ◽  
Andrew C. Edmondson ◽  
Christina Lam ◽  
Christin Johnsen ◽  
Marc C. Patterson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural History ◽  
Randomized Study ◽  
Short Term ◽  
Double Blind ◽  
Natural History Study ◽  
Natural History Studies ◽  
Carbohydrate Deficient Transferrin ◽  
Spontaneous Improvement

AbstractA recent report on long-term dietary mannose supplementation in phosphomannomutase 2 deficiency (PMM2-CDG) claimed improved glycosylation and called for double-blind randomized study of the dietary supplement in PMM2-CDG patients. A lack of efficacy of short-term mannose supplementation in multiple prior reports challenge this study’s conclusions. Additionally, some CDG types have previously been reported to demonstrate spontaneous improvement in glycosylated biomarkers, including transferrin. We have likewise observed improvements in transferrin glycosylation without mannose supplementation. This observation questions the reliability of transferrin as a therapeutic outcome measure in clinical trials for PMM2-CDG. We are concerned that renewed focus on mannose therapy in PMM2-CDG will detract from clinical trials of more promising therapies. Approaches to increase efficiency of clinical trials and ultimately improve patients’ lives requires prospective natural history studies and identification of reliable biomarkers linked to clinical outcomes in CDG. Collaborations with patients and families are essential to identifying meaningful study outcomes.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

A Comparison of Naproxen, Indomethacin and Acetylsalicylic Acid in Pain after Varicose Vein Surgery

1978 ◽  
Vol 6 (2) ◽  
pp. 152-156 ◽  
Author(s):  
Ulla Aromaa ◽  
Kari Asp
Keyword(s):  
Side Effects ◽  
Acetylsalicylic Acid ◽  
Postoperative Analgesia ◽  
Varicose Vein ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Varicose Vein Surgery ◽  
Double Blind ◽  
Post Operative Pain ◽  
Minor Surgery

Oral naproxen in doses of 500 mg and 750 mg daily was compared with oral indomethacin, 75 mg daily, in a double-blind, completely randomized study of patients with post-operative pain after out-patient varicose vein surgery. Altogether, 120 patients were studied. In the study 750 mg naproxen proved to be equal in respect of analgesic efficacy to 75 mg indomethacin, and it was clearly superior to 1500 mg acetylsalicylic acid. Naproxen, 500 to 750 mg daily, afforded adequate postoperative analgesia in 98% of patients. The side-effects were mild. On the basis of the study, naproxen can be recommended as a pain-relieving drug after minor surgery, particularly when an antiphlogistic effect is also desirable.

Ergoloids and Ischaemic Strokes; Efficacy and Mechanism of Action

1995 ◽  
Vol 23 (3) ◽  
pp. 154-166 ◽  
Author(s):  
O Elwan ◽  
AA Helmy ◽  
ME Tamawy ◽  
MA Naseer ◽  
IE Banhawy ◽  
...  
Keyword(s):  
Short Term Memory ◽  
Randomized Study ◽  
Quantitative Difference ◽  
Short Term ◽  
Limb Function ◽  
Double Blind ◽  
The Difference ◽  
Ischaemic Insult ◽  
Assessment Geriatric ◽  
Computerized Electroencephalography

In this double-blind, randomized study the efficacy of the ergoloid compounds, co-dergocrine mesylate and nicergoline, in the rehabilitation of patients with ischaemic stroke was investigated. A group of 30 patients was treated daily with 60 mg nicergoline, orally, and a second group of 27 patients was given 1.8 – 6 mg co-dergocrine mesylate, orally or intramuscularly, daily (depending on the time since the initial ischaemic insult) for 6 months. Outcome measures included: motoricity index (limb function); Sandoz Clinical Assessment Geriatric (SCAG) scale; psychometric tests to assess functions such as attention, psychomotor performance, perception and sensory and short-term memory; conventional and computerized electroencephalography; and P300 and reaction time measures. The results showed improvements in some aspects such as limb function ( P < 0.05), SCAG score ( P < 0.01) and some electrophysiological parameters ( P < 0.01) after treatment with both drugs. Though statistically significant most of the changes were not large. The efficacy of both drugs was qualitatively similar. The quantitative difference in some aspects in favour of nicergoline could be attributed to differences in the mechanisms of action of the two drugs, although it is also possible that the difference may reflect the dosages used. Nootropic drugs may induce a condition that facilitates the effects of cognitive training.

The Effects of Short-Term Immunotherapy Using Molecular Standardized Grass and Rye Allergens Compared with Symptomatic Drug Treatment on Rhinoconjunctivitis Symptoms, Skin Sensitivity, and Specific Nasal Reactivity

2005 ◽  
Vol 133 (4) ◽  
pp. 538-543 ◽  
Author(s):  
L. Klimek ◽  
T. Mewes ◽  
H. Wolf ◽  
I. Hansen ◽  
J. Schnitker ◽  
...  
Keyword(s):  
Drug Treatment ◽  
Grass Pollen ◽  
Randomized Study ◽  
Provocation Test ◽  
Treated Group ◽  
Short Term ◽  
Skin Sensitivity ◽  
Double Blind ◽  
Nasal Provocation ◽  
Significant Difference

BACKGROUND: The efficacy and safety of short-term immunotherapy with molecular standardized allergens (STI) has been demonstrated by double-blind placebo-controlled clinical trials. The aim of this study was to compare STI with symptomatic drug treatment. METHODS: Forty-eight patients with rhinoconjunctivitis to grass and/or rye pollen were treated either with STI (ALK7, n = 24) plus anti-allergic drugs or anti-allergic drugs, alone (n = 24) in a prospective, randomized study. Symptoms and use of drugs were reported in patient diaries and titrated nasal provocation and skin prick tests were performed at baseline, before, and after season. RESULTS: Median overall symptom ( P = 0.022, U test) and medication scores ( P = 0.003) were significantly lower in the STI group, as was the result for a simultaneous analysis of conjunctival, nasal, and bronchial symptom scores and medication ( P = 0.005). Sensitivity in the nasal provocation test decreased in the STI group but not in the drug-treated group. These differences became significant directly after STI ( P = 0.027) as well as after the grass pollen season ( P < 0.001). Skin sensitivity did not change in the STI group but increased in the drug-treated group after season, with a significant difference between the two groups for the erythema ( P < 0.001). CONCLUSIONS: STI reduces grass pollen-induced rhinoconjunctivitis symptoms and drug use, and specific nasal reactivity and skin sensitivity, more efficiently than a standard symptomatic treatment.

scholarly journals Intrathecal chloroprocaine or hyperbaric prilocaine for ambulatory knee surgery? A prospective randomized study

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
E Guntz ◽  
C Vasseur ◽  
D Ifrim ◽  
A Louvard ◽  
J F Fils ◽  
...  
Keyword(s):  
Side Effects ◽  
Knee Arthroscopy ◽  
Randomized Study ◽  
Sensory Block ◽  
Double Blind Study ◽  
Double Blind ◽  
Number Of Patients ◽  
Prolonged Duration ◽  
Registration Number ◽  
Dermatomal Level

Abstract Purpose The aim of this study was to compare intrathecal 1% chloroprocaine with 2% hyperbaric prilocaine in the setting of ambulatory knee arthroscopy. We hypothesized that complete resolution of the sensory block was faster with chloroprocaine. Methods Eighty patients scheduled for knee arthroscopy were included in this prospective randomized double-blind study. Spinal anesthesia was performed with either chloroprocaine (50 mg) or hyperbaric prilocaine (50 mg). Characteristics of sensory and motor blocks and side effects were recorded. Results Mean time to full sensory block recovery was shorter with chloroprocaine (169 (56.1) min vs 248 (59.4)). The characteristics of the sensory blocks were similar at the T12 dermatome level between the two groups. Differences appeared at T10: the percentage of patients with a sensory block was higher, onset quicker and duration longer with hyperbaric prilocaine. The number of patients with a sensory block at T4 dermatome level in both groups was minimal. Times to full motor recovery were identical in both groups (85 (70–99) vs 86 (76–111) min). Time to spontaneous voiding was shorter with chloroprocaine (203 (57.6) min vs 287.3 (47.2) min). Incidence of side effects was low in both groups. Conclusions When considering the characteristics of the sensory block, the use of chloroprocaine may allow an earlier discharge of patients. Cephalic extension was to a higher dermatomal level and the sensory block at T10 level was of prolonged duration with hyperbaric prilocaine, suggesting that the choice between the two drugs should also be performed based on the level of the sensory block requested by the surgery. This study is registered in the US National Clinical Trials Registry, registration number: NCT030389, the first of February 2017, Retrospectively registered.

scholarly journals Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Nikola Besic ◽  
Jaka Smrekar ◽  
Branka Strazisar
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Acute Pain ◽  
Randomized Study ◽  
Double Blind Study ◽  
Breast Cancer Patients ◽  
Dose Frequency ◽  
Double Blind ◽  
Axillary Lymphadenectomy

Abstract The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.

Ranitidine in the Treatment of Duodenal and Prepyloric Ulcer: Comparison of Two Dosage Regimens

1983 ◽  
Vol 11 (3) ◽  
pp. 167-172 ◽  
Author(s):  
H Brunner ◽  
F X Pesendorfer ◽  
R Pötzi
Keyword(s):  
Side Effects ◽  
Mucosal Inflammation ◽  
Controlled Study ◽  
Short Term ◽  
Double Blind ◽  
Laboratory Findings ◽  
Dosage Regimens ◽  
Prepyloric Ulcer ◽  
Daily Dose

In a double-blind controlled study eighty-two patients with duodenal or prepyloric ulcer were treated with either 100 mg or 150 mg ranitidine twice daily. After 4 weeks of treatment the ulcer had healed in twenty-two of forty-one patients (54%) on 200 mg of ranitidine and in thirty-six of forty-one patients (88%) on 300 mg of ranitidine. In the x2-test this difference was statistically significant (p < 0·01). Relief of pain and reduction of mucosal inflammation were similar in both groups. There were no drug-related side-effects nor consistent changes in laboratory findings. We conclude that a daily dose of 300 mg ranitidine is superior to 200 mg ranitidine in the treatment of duodenal and prepyloric ulcer and that the short-term use of ranitidine seems to be safe for the treatment of these ulcers.

scholarly journals Polymorphism of μ-Opioid Receptor Gene (OPRM1:c.118A>G) Might Not Protect against or Enhance Morphine-Induced Nausea or Vomiting

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Li-Kuei Chen ◽  
Shiou-Sheng Chen ◽  
Chi-Hsiang Huang ◽  
Hong-Jyh Yang ◽  
Chen-Jung Lin ◽  
...  
Keyword(s):  
Side Effects ◽  
Opioid Receptor ◽  
Receptor Gene ◽  
Randomized Study ◽  
Patient Control Analgesia ◽  
Morphine Consumption ◽  
Nucleotide Position ◽  
Double Blind ◽  
Significant Difference ◽  
Equilibrium Test

A cohort, double blind, and randomized study was conducted to investigate the effect of a single nucleotide polymorphism of the μ-opioid receptor at nucleotide position 118 (OPRM1:c.118A>G) on the association with the most common side effects (nausea or vomiting) induced by intravenous patient control analgesia (IVPCA) with morphine, including incidence and severity analysis. A total of 129 Taiwanese women undergoing gynecology surgery received IVPCA with pure morphine for postoperative pain relief. Blood samples were collected and sequenced with high resolution melting analysis to detect three different genotypes of OPRM1 (AA, AG, and GG). All candidates 24 h postoperatively will be interviewed to record the clinical phenotype with subjective complaints and objective observations. The genotyping after laboratory analysis showed that 56 women (43.4%) were AA, 57 (44.2%) were AG, and 16 (12.4%) were GG. The distribution of genotype did not violate Hardy-Weinberg equilibrium test. There was no significant difference neither between the severity and incidence of IVPCA morphine-induced side effects and genotype nor between the association between morphine consumption versus genotype. However, there was significant difference of the relation between morphine consumption and the severity and incidence of IVPCA morphine-induced nausea and vomiting. The genetic analysis for the severity and incidence of IVPCA morphine-induced nausea or vomiting showed no association between phenotype and genotype. It might imply that OPRM1:c.118A>G does not protect against IVPCA morphine-induced nausea or vomiting.

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