Comparison of pretreatment with low-dose midazolam in combination with fentanyl and midazolam alone on the occurrence of etomidate-induced myoclonus—a randomized, double-blind study

Abstract Background Myoclonus is reported to occur in 50–80% of patients receiving etomidate in the absence of pretreatment. The study aimed to evaluate the efficacy of pretreatment with low-dose midazolam and fentanyl, and midazolam alone to reduce the occurrence of etomidate-induced myoclonus. Sixty patients were randomly divided into 2 groups. In group MF, patients received pretreatment with intravenous (IV) midazolam 0.015mg/kg in a volume of 5 ml normal saline, followed by IV fentanyl 1μg/kg in a volume of 5 ml normal saline. In group M, patients received pretreatment with IV midazolam 0.03mg/kg in a volume of 5 ml normal saline, followed by 5ml of IV normal saline. The test drug was injected over 30 s, and after 120 s, IV etomidate 0.3 mg/kg was injected over 30 s. The patients were observed for 120 s for myoclonus and graded as mild, moderate, or severe. Heart rate, blood pressure, and oxygen saturation were recorded immediately after test drug injection and at every minute for 5 min. Results The demographic parameters and hemodynamic parameters were comparable between the two groups. In group M, the incidence of myoclonus was 36.67% (26.67% mild and 10% moderate) whereas, in the group MF, the incidence of myoclonus was 26.67% (3.33% mild, 16.67% moderate, and 6.67% severe). This incidence of myoclonus was significantly lower in group MF (p=0.030). Conclusions The incidence of etomidate-induced myoclonus is significantly lower in patients pretreated with midazolam and fentanyl combination as compared to midazolam alone. Trial registration Clinical Trial Registry Details: CTRI/2019/05/018920

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The Optimal Administration Time of Butorphanol in Suppressing Sufentanil-induced Cough: A Single-Center Randomized Double-Blind Trial

10.21203/rs.3.rs-74936/v1 ◽

2020 ◽

Author(s):

Yuejiao Song ◽

Zhihong Xu ◽

Zhenyi Chen ◽

Qingwu Liao

Keyword(s):

Normal Saline ◽

Anesthesia Induction ◽

Double Blind Trial ◽

Trial Registry ◽

Single Center ◽

Clinical Trial Registry ◽

Double Blind ◽

Significant Difference ◽

Administration Time ◽

Registration Number

Abstract Backgroud: To evaluate the optimal administration time of butorphanol in suppressing sufentanil-induced cough(SIC) during the induction of general anesthesia.Methods:180 patients were randomly divided into 4 equally sized groups: at 5min, 2min and 0min before anesthesia induction, all patients were sequentially injected the drug labeled A/B/C (butorphanol 1mg or normal saline), GI received intravenously drug A/B/C (All were normal saline),GII received intravenously drug A/B/C (A was butorphanol, B and C were saline), GIII received intravenously drug A/B/C (B is butorphanol, A and C were saline), GIV received intravenously drug A/B/C (C is butorphanol，A and B were saline). ALL Patients were then administrated with sufentanil 0.4 µg/kg in 5s after drug C. The incidence and severity of SIC was recorded within 2 minutes after sufentanil injection. MAP, HR, and SpO2 were recorded at T0 (before the administration of any drug),Ta, Tb, Tc (before the injection of drug A/B/C), T1( 2minutes after sufentanil injection) and T2 (1 minutes after endotracheal intubation). Results: The incidences of cough in GII, GIII, and IV were lower than that in GI (0.09, 0.01, and 0 vs 42.2%, P<0.01), while there were no significant differences between GII, GIII, and GIV. The HR of all 4 groups at T2 were significantly higher than their levels at any other time (P<0.05,T2 vs other time), but there’s no significant difference among 4 groups at T2. The MBP of all 4 groups at Ta and Tb were significantly lower than their levels at any other time (P<0.05, Ta and Tb vs other time), but there’s no significant difference among 4 groups at Ta and Tb. At Ta, the SpO2 of GII was significantly lower than GI, GIII and GIV (P<0.05); at Tb, the SpO2 of GII was significantly lower than GI (P<0.05) and GIV (P<0.01); at Tc, the SpO2 of GIII were significantly lower than GIV (P<0.05).Conclusion: Intravenous butorphanol 1 mg could effectively suppress SIC before sufentanil injection. Without waiting time before administering the sufentanil may be feasible in clinical practice, it has the same suppressive effection and has no influence on BP, HR, SpO2 and the total amount of sufentanil. Trial registration: Chinese Clinical Trial Registry with registration number ChiCTR1900024394. Registered 9 July 2019.

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Baricity, Needle Direction, and Intrathecal Sufentanil Labor Analgesia

Anesthesiology ◽

10.1097/00000542-199703000-00010 ◽

1997 ◽

Vol 86 (3) ◽

pp. 592-598 ◽

Cited By ~ 37

Author(s):

Fazeela Ferouz ◽

Mark C. Norris ◽

Valerie A. Arkoosh ◽

Barbara L. Leighton ◽

Louis M. Boxer ◽

...

Keyword(s):

Side Effects ◽

Pain Relief ◽

Normal Saline ◽

Analgesic Efficacy ◽

Study Drug ◽

Labor Analgesia ◽

Labor Pain ◽

Double Blind Study ◽

Drug Injection ◽

Double Blind

Background Intrathecal sufentanil relieves labor pain but centrally mediated side effects are common. Preventing rostral spread of intrathecal sufentanil should limit these side effects. Both direction of the lateral opening of a pencil-point needle and drug baricity modify the spread of intrathecal local anesthetics. This randomized, prospective, double-blind study examines the effects of these variables on intrathecal sufentanil labor analgesia. Methods Forty laboring, full-term parturients, whose cervixes were dilated less than 5 cm and who requested analgesia for labor were enrolled. Combined spinal epidural analgesia was induced in patients in the sitting position. They were allocated to receive 10 micrograms intrathecal sufentanil diluted with either normal saline or dextrose with the aperture of the pencil-point needle directed cephalad or caudad during drug injection. Thus there were four groups of ten patients: dextrose up, dextrose down, saline up, and saline down. Sufentanil was diluted with normal saline to a concentration of 10 micrograms/ml. The study drug was made by mixing 1 ml sufentanil solution with either 1 ml 10% dextrose or 1 ml normal saline. Visual analog scores for pain, pruritus, nausea, and pain relief were recorded before and 5, 10, 15, and 30 min after drug injection. Results Baricity, but not needle orientation, influenced pain relief and pruritus. Sufentanil in dextrose produced less itching but also less analgesia. Nine of 20 women in the dextrose groups compared with 1 of 20 in the saline groups requested additional analgesia by 30 min. Conclusions Little or no labor analgesia developed for patients receiving sufentanil with dextrose. A supraspinal action may contribute to intrathecal sufentanil's analgesic efficacy.

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A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

Scandinavian Journal of Pain ◽

10.1016/j.sjpain.2010.05.035 ◽

2010 ◽

Vol 1 (3) ◽

pp. 122-141 ◽

Cited By ~ 43

Author(s):

Harald Breivik ◽

Tone Marte Ljosaa ◽

Kristian Stengaard-Pedersen ◽

Jan Persson ◽

Hannu Aro ◽

...

Keyword(s):

Side Effects ◽

Pain Relief ◽

Low Dose ◽

Rating Scale ◽

Secondary Outcome ◽

Double Blind Study ◽

Double Blind ◽

Skin Reactions ◽

Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

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Studies On Coagulation Physiology In Perioperative Thromboembolism Prophylaxis In Surgery

10.1055/s-0038-1651987 ◽

1981 ◽

Author(s):

K Koppenhagen ◽

A Häring ◽

H Zühlke ◽

A Wiechmann ◽

M Matthes ◽

...

Keyword(s):

Side Effects ◽

Blood Coagulation ◽

Low Dose ◽

Combination Group ◽

Double Blind Study ◽

Thrombin Time ◽

Thromboembolism Prophylaxis ◽

Double Blind ◽

Heparin Plasma ◽

Low Dose Heparin

In a prospective and randomized double-blind study in 630 general surgery patients with different thromboembolism prophylaxis (130 patients with 5000 and 122 with 2500 I.U. of heparin, 128 with a fixed combination of 2500 I.U. of heparin and 0.5 mg dihydroergotamine ((2500-heparin-DHE)), 124 with 0.5 mg DHE and 126 with a placebo, 3 × daily) the influence of the medication on blood coagulation was examined by repeated pre-and post-operative determinations of blood-and coagulation parameters (activated partial thromboplastin time, heparin-plasma level, AT III, thromboplastin time, fibrinogen, thrombin time, thrombocyte aggregation test, β-thromboglobulin, Hb, erythrocytes, hematocrit, thrombocytes and differential blood picture). The frequency of postoperative thromboses and pulmonary embolisms was investigated by means of the radiofibrinogen test and lung scintigraphy. The results show that the lowest thromboembolism rate occurs in that patient collective in which there is in addition to the heparin application a simultaneous hemostatic effect of DHE. Side effects of the prophylaxis and influences on blood coagulation are dependent on the amount of heparin administered both in the single-drug low-dose treatment and in the combination therapy. The lowest rate of side effects was found in the group receiving 3×2500 I.U. of heparin and in the combination group 2500-heparin-DHE, but the combination treatment additionally affords the same thromboembolism protection as the routinely applied 3×5000 I.E. of low dose heparin.

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5.21 EVALUATION OF THE EFFICACY AND SAFETY OF SHP465 MIXED AMPHETAMINE SALTS AT A LOW DOSE IN CHILDREN WITH ADHD: RESULTS FROM A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY

Journal of the American Academy of Child & Adolescent Psychiatry ◽

10.1016/j.jaac.2019.08.335 ◽

2019 ◽

Vol 58 (10) ◽

pp. S252

Author(s):

Greg Mattingly ◽

Valerie Arnold ◽

Brian Yan ◽

Ming Yu ◽

Brigitte Robertson

Keyword(s):

Low Dose ◽

Blind Study ◽

Double Blind Study ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Children With Adhd

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Low-dose aspirin and uterine haemodynamics on the day of embryo transfer in women undergoing IVF/ICSI: a randomized, placebo-controlled, double-blind study

Human Reproduction ◽

10.1093/humrep/den489 ◽

2008 ◽

Vol 24 (4) ◽

pp. 861-866 ◽

Cited By ~ 19

Author(s):

M. Haapsamo ◽

H. Martikainen ◽

J. Rasanen

Keyword(s):

Embryo Transfer ◽

Low Dose ◽

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

Dose Aspirin ◽

Low Dose Aspirin ◽

Day Of Embryo Transfer

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Subjective Experience and D2Receptor Occupancy in Patients With Recent-Onset Schizophrenia Treated With Low-Dose Olanzapine or Haloperidol: A Randomized, Double-Blind Study

American Journal of Psychiatry ◽

10.1176/appi.ajp.160.2.303 ◽

2003 ◽

Vol 160 (2) ◽

pp. 303-309 ◽

Cited By ~ 83

Author(s):

Lieuwe de Haan ◽

Marion van Bruggen ◽

Jules Lavalaye ◽

Jan Booij ◽

Peter M.A.J. Dingemans ◽

...

Keyword(s):

Subjective Experience ◽

Low Dose ◽

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

Recent Onset

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Comparison of the Perioperative and Postoperative Effects of Levobupivacaine and of Levobupivacaine + Adrenaline in Pediatric Tonsillectomy: A Double-Blind Randomized Study

Pain Research and Management ◽

10.1155/2017/8431823 ◽

2017 ◽

Vol 2017 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Faruk Cicekci ◽

Cigdem Sizer ◽

Sait Selcuk Atici ◽

Sule Arican ◽

Adnan Karaibrahimoglu ◽

...

Keyword(s):

Postoperative Pain ◽

Randomized Study ◽

Oral Intake ◽

Postoperative Nausea And Vomiting ◽

Trial Registry ◽

Zealand Clinical Trial Registry ◽

Clinical Trial Registry ◽

Double Blind ◽

Total Consumption ◽

Pain Scores

Objectives. We aimed to assess the effects of levobupivacaine and of levobupivacaine + adrenaline administered during pediatric tonsillectomy on the postoperative period. Methods. A total of 90 patients between the ages of five and twelve were divided randomly into two groups before tonsillectomy: levobupivacaine only (0.5%) 0.4 mg·kg−1 or levobupivacaine (0.5%) 0.4 mg·kg−1 + adrenaline (1 : 200.000) administered by means of peritonsillar infiltration. Primary outcomes were postoperative pain scores recorded at various intervals until 24 hours postoperatively. Secondary outcomes included postoperative nausea and vomiting (PONV), time to first oral intake, time to the first administration of analgesics and total consumption of analgesics, and the amount of bleeding for all children. Results. In both groups, patients had the same postoperative pain scores and PONV rates, and equal amounts of analgesics were consumed up to 24 hours postoperatively. The two groups also had the same time until first oral intake, recovery time and time to the first analgesic request, and amount of bleeding. Conclusions. Perioperative levobupivacaine infiltration on its own is a valid alternative to the combination of levobupivacaine + adrenaline for perioperative and postoperative effectiveness in pediatric tonsillectomy. This trial is registered with Australian New Zealand Clinical Trial Registry ACTRN: ACTRN12617001167358.

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