Randomized, Double-blind Study of the Analgesic Efficacy of Morphine-6-Glucuronide versus  Morphine Sulfate for Postoperative Pain in Major Surgery

2005 ◽  
Vol 102 (4) ◽  
pp. 815-821 ◽  
Author(s):  
Magdi H. Hanna ◽  
Kate M. Elliott ◽  
Michelle Fung

Background Morphine-6-glucuronide (M6G) has promising preclinical characteristics and encouraging pharmacokinetic features for acute nociceptive pain. Early studies have produced a good safety profile when compared to morphine sulfate, although in surrogate pain models studies, a mixed picture emerged. A study to evaluate the efficacy and safety profile in a clinical setting was designed. Methods The authors conducted a double-blind, randomized, dose-finding study of patients scheduled to undergo major joint replacement. One hundred patients of both sexes were included, with 50 patients in each group. A loading dose of 10 mg of study medication was given intravenously at induction of anesthesia, and two further doses were allowed during surgery if required. Bolus doses via a patient-controlled analgesia system were given subcutaneously at 2 mg/dose and set at a 10-min lockout. Assessments of pain intensity and relief were recorded during the 24-h period. Results There were no statistically significant differences between the treatments for 24-h mean pain intensity. However, pain intensity was significantly higher in the M6G group than in the morphine group at 30 min and 1 h. There was no statistical difference in 24-h mean pain relief or retrospective pain scores at any time point during the 24-h period. The severity of sedation was significantly greater in the morphine group than in the M6G group at 30 min, 1 h, 2 h, and 24 h. Respiratory depression was greater in the morphine group than in the M6G group, and more patients in the morphine group withdrew from the study because of respiratory depression. Conclusions Overall, M6G has an analgesic effect similar to that of morphine over the first 24 h postoperatively. However, M6G may be slower onset initially than morphine; therefore, a larger initial dose may be required.

2020 ◽  
Vol 11 (4) ◽  
pp. 6188-6195
Author(s):  
Jones Jayabalan ◽  
Muthusekhar M R ◽  
Senthil Murugan P

The study aimed to compare the analgesic efficacy of 100 mg and 20 mg as a analgesic for preventing post-operative pain after third molar surgery. Fifty patients with impacted mandibular third molars who required surgical removal were included in the study. These patients were divided into two groups randomly. One group consisted of patients receiving 100 mg as a analgesic, and the other group consisted of patients receiving 20 mg as a analgesic 1 hour before the procedure. The study findings show both the drugs were equally effective in managing post-operative pain following third molar surgery. On statistical analysis, there was no significant difference in pain experience among both groups A and B in post-operative period who underwent surgery. However, the study observes a highly significant difference in both the groups in terms of pain intensity scores at different times. Results show that there was a significant difference before, 3rd day and 5th day; Further study shows that the effectiveness of the drug was not confirmed in 24 hours to 3 days. It was observed both the groups shows a significant difference in on the 5thand 3rd day. This comparative research of pain intensity shows after analgesia with and in of third molars, a pronounced effect in the group treated with 20mg was seen. Still, there was no statistically significant difference noted in VAS before and 5th day of both groups.


1979 ◽  
Vol 7 (3) ◽  
pp. 240-246 ◽  
Author(s):  
Leo Winter ◽  
Arthur Post

Two hundred male and female patients underwent a variety of oral surgical procedures and were treated qfterwards in four test groups. They took a combination of orphenadrine (25 mg) and acetaminophen (325 mg), either drug alone, or placebo. A double-blind study design was used. All patients had moderately severe baseline pain intensity; post-treatment pain relief was recorded at 30 minutes, one, two, four and six hours. A back-up analgesic (codeine-ASA) was made available if needed. Pain intensity difference (PID) and sums of pain intensity difference (SPID) were calculated using established analgesic study techniques. Statistical analyses indicated better analgesic efficacy in both PID and SPID scores for the orphenadrine-acetaminophen combination over the three other treatments. This was evident at 30 minutes and continued through the sixth hour. Each active drug, in turn, was also significantly better throughout than placebo for pain relief. Sub-groups in each treatment regimen required additional pain relief prior to six hours, with significantly more placebo than orphenadrine-acetaminophen patients needing remedication. Side-effect incidence was very low and randomly distributed among the four groups-


2020 ◽  
Vol 34 (12) ◽  
pp. 5477-5483 ◽  
Author(s):  
Jarno Jokelainen ◽  
Anna Belozerskikh ◽  
Harri Mustonen ◽  
Marianne Udd ◽  
Leena Kylänpää ◽  
...  

Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. Methods This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2 < 90%). Mann–Whitney test for continuous variables and Fisher’s exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups. Results There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer’s Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters. Conclusions Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.


2020 ◽  
Vol 277 (4) ◽  
pp. 1095-1100 ◽  
Author(s):  
İrem Ates ◽  
Muhammed Enes Aydin ◽  
Ali Ahiskalioglu ◽  
Elif Oral Ahiskalioglu ◽  
Zulkuf Kaya ◽  
...  

2019 ◽  
Vol 36 (3) ◽  
pp. 142-147 ◽  
Author(s):  
Michelle Seiler ◽  
Georg Staubli ◽  
Markus A. Landolt

ObjectiveNitrous oxide 70% (N2O 70%) is an excellent medication for procedural analgosedation (PAS), yet the limit of its analgesic power remains uncertain; therefore, a combination with intranasal fentanyl (INF) was suggested. However, this combination seems to result in a higher rate of vomiting and deeper sedation. This study aimed at assessing the analgesic efficacy, sedation depth and rate of adverse events of PAS with N2O 70% with and without INF.MethodsPatients aged 2–16 years who qualified for PAS with N2O 70% were randomly assigned to receive either INF or placebo prior to N2O inhalation in this randomised, double-blind study, which was performed in a tertiary children’s hospital ED between September 2015 and October 2017. Behaviour during the procedure was evaluated using the Face, Leg, Activity, Cry and Consolability (FLACC) scale and the Modified Behavioural Pain Scale (MBPS); analgesic efficacy was assessed with a self-reported pain scale. Sedation depth using the validated University of Michigan Sedation Scale and adverse events in the ED and during the following 12 hours were documented.ResultsA total of 402 patients were included; 3 did not tolerate N2O and therefore had to be excluded. Overall, 399 patients were analysed, of whom 201 (50.4%) received INF. No significant group differences with regard to FLACC scale score, self-reported pain, MBPS score and sedation depth were found. In addition, the two groups did not differ with regard to all types of adverse events.ConclusionCombining N2O 70% with INF resulted in no differences with regard to FLACC scale score, self-reported pain, MBPS score, patient and parental satisfaction rate, sedation depth, and adverse events.Trial registration numberNCT02533908


1997 ◽  
Vol 86 (3) ◽  
pp. 592-598 ◽  
Author(s):  
Fazeela Ferouz ◽  
Mark C. Norris ◽  
Valerie A. Arkoosh ◽  
Barbara L. Leighton ◽  
Louis M. Boxer ◽  
...  

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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