Analgesic Efficacy and Side-Effect Profile of Paracetamol/Codeine and Paracetamol/Dextropropoxyphene after Surgical Removal of a Lower Wisdom Tooth

1987 ◽  
Vol 15 (2) ◽  
pp. 83-88 ◽  
Author(s):  
S. Sagne ◽  
P.-Å. Henrikson ◽  
K.-E. Kahnberg ◽  
H. Thiiander ◽  
S. O. Bertilson

A double-blind randomized analgesic trial was carried out on 180 patients undergoing surgical removal of an impacted lower wisdom tooth. The patients took their first dose of either 1000 mg paracetamol plus 60 mg codeine or 650 mg paracetamol plus 65 mg dextropropoxyphene when pain appeared after the decline of the local anaesthesia. If needed, another two doses were available during the observation period (≤10 h). The analgesic efficacy of paracetamol/codeine was overall superior to paracetamol/dextropropoxyphene in all variables. Sufficient pain relief was obtained in most patients. The pain reduction after the first dose was 64% in the group receiving paracetamol/codeine compared with 53% in the group receiving paracetamol/dextropropoxyphene and the mean durations of effect of the first dose were 6.6 and 5.8 h, respectively. Side-effects appeared in all patient groups but were most frequent in women taking paracetamol/codeine.

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.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Siddhartha Handa ◽  
MS Sangolli ◽  
Sanjay Panchal

Abstract Aim To study the effectiveness of intraperitoneal instillation of tramadol for postoperative laparoscopic cholecystectomy (LC) pain relief and improve incidence of adverse effect. Methods Double blinded randomized controlled trial over 1 year. The Ethical Clearance was obtained from Institutional Ethics Committee. 60 patients scheduled for LC were enrolled in the study. Patients were randomly assigned into 2 groups using computer generated random numbers. Group T: Received intraperitoneal tramadol 100 mg (diluted in 20 mls distilled water). Group S: Received 20 ml of intraperitoneal normal saline. Pain was assessed using VAS. The assessment was done at 0, 15, 30, 60 minutes, 4, 8, 12, 16 and 24 hours. Incidence of adverse effect were observed. Results In group T, the mean pain scores at all the intervals were significantly low (p < 0.050) except at 24 hours (p = 0.210). Analgesia requirement was significantly high in group S compared to group T immediate post op, 15, 60 minutes, 8 and 12 hours (p < 0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 and 8 hours was significantly low in group T compared to group S (p < 0.050). 30% patients in group T did not require analgesia at all compared to S (p < 0.001). Incidence of adverse effects at 4 hours was 43% in group S compared to 40% in group T (p > 0.050). Conclusion Intraperitoneal instillation of tramadol in LC has beneficial effect in terms of postoperative pain relief following LC and lower requirement of analgesia. However, the incidence of adverse effects was comparable in both the groups.


1970 ◽  
Vol 3 (1) ◽  
pp. 14-18 ◽  
Author(s):  
O Kuti ◽  
AF Faponle ◽  
AB Adeyemi ◽  
AT Owolabi

Aim: To assess and compare the analgesic efficacy and side effects of Pentazocine and Tramadol. Method: This double blind randomised controlled trial was carried out at the labour ward of Wesley Guild Hospital Ilesa Nigeria. One hundred normal pregnant women in active labour at term were randomly assigned to receive either intramuscular Pentazocine 30mg or intramuscular tramadol 100mg, at request for analgesia. Analgesic efficacy was assessed by verbal scales of pain intensity and relief; maternal and neonatal side effects were determined. Results: At 60 minutes after drug administration 47.7% and 30.9% of women, in the pentazocine and tramadol group respectively, experienced moderate to good pain relief. Significantly more women in the pentazocine group (34.1%) than in the tramadol group(14.3%) rated their pain as mild (P < 0.05) sixty minutes after drug administration. Mean time to first subsequent request for analgesia was greater in the pentazocine group (181 minutes vs 113 minutes; P < 0.05). There was no significant differences between the drugs in maternal side effects, labour and neonatal outcomes. Conclusion: Pentazocine provides better pain relief than tramadol in labor. Key words: Labour pain, pentazocine, tramadol doi:10.3126/njog.v3i1.1433NJOG 2008 May-June; 3(1): 14 - 18


1979 ◽  
Vol 7 (2) ◽  
pp. 107-116 ◽  
Author(s):  
P-Å Henrikson ◽  
A Tjernberg ◽  
U Ahlström ◽  
L-E Peterson

In a double-blind clinical trial a new, non-steroidal anti-inflammatory agent with analgesic properties, Fenbufen, was compared to acetylsalicylic acid (ASA) and placebo. Six hundred (600) out-patients, following surgical removal of an impacted lower wisdom tooth, were divided into three groups and randomly given either Fenbufen (500 mg capsules), ASA (750 mg capsules), or placebo. One capsule was taken immediately after the surgical procedure, followed by another capsule every 6 hours. The duration of treatment was 24 hours. Thus, a total of 4 capsules were taken. Self-evaluation forms were provided to the patients and were returned to the investigators the following day. The results were statistically analyzed. Both Fenbufen and ASA were statistically superior (p ≤ 0.01) to placebo in relieving pain. A comparison of the Fenbufen and ASA groups demonstrated a statistically significant (p ≤ 0.05) superiority for Fenbufen in relieving pain. Also sleep was less disturbed in the Fenbufen group. Side-effects reported were few, minor in character, and fewer in number in the Fenbufen group.


1987 ◽  
Vol 15 (2) ◽  
pp. 89-95 ◽  
Author(s):  
J. Jacobson ◽  
S. O. Bertilson

Pain after episiotomy and/or perineal/vaginal rupture in childbirth is severe in many patients and in most cases it can be treated with oral analgesics. In this trial the efficacy and side-effect profile of two combination analgesics, paracetamol/codeine and paracetamol/dextropropoxyphene hydrochloride, were compared in post-partum pain after episiotomy and/or rupture of the perineum. Eighty-five patients were analysed for efficacy and 96 were included in an analysis of side-effects. Paracetamol/codeine was shown to give faster and more efficient pain relief while not causing constipation or other troublesome side-effects.


1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.


2019 ◽  
Vol 47 (9) ◽  
pp. 4225-4229
Author(s):  
Muharrem Ucar ◽  
Fatih Oguz ◽  
Ilhan Gecit ◽  
Mustafa Said Aydogan

Objective Cystoscopy is a common urologic procedure. Analgesics are often used to reduce any pain associated with this procedure. The aim of this study was to investigate the efficacy in reducing pain and the cost-effectiveness of two forms of lidocaine gel in patients undergoing cystoscopy. Methods In this double-blind, randomized clinical trial, 77 male patients who were referred for double J removal, urethral dilatation, or cystoscopy were enrolled. The patients were divided into two groups: Dispogel and Cathejell. All patients received 20 mL of intraurethral lidocaine gel 2% and cystoscopy was performed 5 minutes thereafter. The primary outcome was the pain score (visual analogue scale, VAS) during and 5 minutes after cystoscopy. Results There were no statistically significant differences between the VAS scores, blood pressure, and pulse rate in the groups in either observation period. No patient required additional anesthetic agents or sedatives for insufficient pain relief. Conclusion The results of this study show that the analgesic efficacy of Dispogel and Cathejell in the treatment of pain during and after elective cystoscopy was the same, but Dispogel was more cost-effective.


2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  

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.


2017 ◽  
Vol 6 (3) ◽  
pp. 26-32
Author(s):  
G P Deo ◽  
S K Shrestha ◽  
I N Shrestha

To compare the efficacy of epidural butorphanol and tramadol for post operative analgesia in lower limb surgeries. Randomized, controlled, double blind, prospective study conducted at Department of Anaesthesia and Critical Care, Chitwan Medical College from September 1st 2015 to August 31st 2016. 60 patients of ASA Grade I and II of either sex, aged between 18-65 years willing for epidural analgesia for post operative analgesia were included in the study. They were divided into two groups: Group B- Butorphanol group and Group T- Tramadol group. Subjects of Group B received 2mg of Butorphanol and 0.25% Bupivacaine making a total volume of 10 ml and that of Group T received 100mg of Tramadol and 0.25% Bupivacaine also making a total volume of 10 ml. Analgesic efficacy was assessed by Visual Analogue Scale (VAS). The onset and duration of analgesia along with side effects were also assessed. The quality of analgesia was studied using time to independent mobilization and overall patient satisfaction. Total number of patients was 60, of ASA Grade I and II, aged between 18-65 years. The mean age of patients in Group B was 42.6±11.7 years and 46.1±11.2 years in Group T. Time of onset of analgesia after epidural injection was 7.4±0.9 minutes in Group B and 12.7±1.5 minutes in Group T and the difference was found to be statistically significant. Duration of analgesia was 317.1±99.1 minutes and 438.8±136.6 minutes in Butorphanol and Tramadol groups respectively which was also statistically significant. Sedation was significantly higher in butorphanol group whereas nausea and vomiting was higher in tramadol group. Quality of analgesia in terms of patient satisfaction was better with epidural butorphanol. Both epidural tramadol and butorphanol were effective in relieving post operative pain however butorphanol had lesser side effects and greater patient satisfaction compared to tramadol but the duration of action was relatively short.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023715 ◽  
Author(s):  
Cosme Gay-Escoda ◽  
Magdi Hanna ◽  
Antonio Montero ◽  
Thomas Dietrich ◽  
Stefano Milleri ◽  
...  

ObjectivesTo compare efficacy/safety of oral tramadol 75 mg/dexketoprofen 25 mg (TRAM/DKP) and TRAM 75 mg/paracetamol 650 mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar.DesignMulticentre, randomised, double-blind, placebo-controlled, phase IIIb study.ParticipantsHealthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis.InterventionsSurgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (≥4) within 4 hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25 mg, TRAM/paracetamol 75/650 mg or placebo.Main outcome measuresEfficacy was based patients’ electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0=‘no relief’, 1=‘a little (perceptible) relief’, 2=‘some (meaningful) relief’, 3=‘lot of relief’, 4=‘complete relief’) at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6 hours (TOTPAR6). Rescue medication was available during the treatment period.ResultsTRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.1 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups.ConclusionsTRAM/DKP (75/25 mg) is effective and superior to TRAM/paracetamol (75/650 mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile.Trial registration numberEudraCT 2015-004152-22 and NCT02777970.


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