scholarly journals Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study

2021 ◽  
Author(s):  
Gaute Lyngstad ◽  
Per Skjelbred ◽  
David M. Swanson ◽  
Lasse A. Skoglund
Keyword(s):  
Single Dose ◽  
Pain Intensity ◽  
Effect Size ◽  
Analgesic Effect ◽  
Intensity Difference ◽  
Double Blind ◽  
Pain Intensity Difference ◽  
Calculated Effect ◽  
Maximum Pain ◽  
Size Estimates

Abstract Purpose Effect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates. Methods A randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp. Results Ibuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose–response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs. Conclusion Ibuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators. Trial registration NCT00699114.

Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty

2015 ◽  
Vol 123 (2) ◽  
pp. 434-443 ◽  
Author(s):  
Maurice Jove ◽  
David W. Griffin ◽  
Harold S. Minkowitz ◽  
Bruce Ben-David ◽  
Mark A. Evashenk ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Hip Arthroplasty ◽  
Intensity Difference ◽  
Double Blind Study ◽  
Double Blind ◽  
Sublingual Tablet ◽  
Pain Intensity Difference ◽  
Major Orthopedic Surgery ◽  
American Society ◽  
American Society Of Anesthesiologists

Abstract Background: Complications with IV patient-controlled analgesia include programming errors, invasive access, and impairment of mobility. This study evaluated an investigational sufentanil sublingual tablet system (SSTS) for the management of pain after knee or hip arthroplasty. Methods: This prospective, randomized, parallel-arm, double-blind study randomized postoperative patients at 34 U.S. sites to receive SSTS 15 μg (n = 315) or an identical placebo system (n = 104) and pain scores were recorded for up to 72 h. Adult patients with American Society of Anesthesiologists status 1 to 3 after primary total unilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible. Patients were excluded if they were opioid tolerant. The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48 h. Secondary endpoints included total pain relief, patient and healthcare professional global assessments, and patient and nurse ease-of-care questionnaires. Results: Summed pain intensity difference (standard error) was higher (better) in the SSTS group compared with placebo (76 [7] vs. −11 [11], difference 88 [95% CI, 66 to 109]; P < 0.001). In the SSTS group, more patients and nurses responded “good” or “excellent” on the global assessments compared with placebo (P < 0.001). Patient and nurse ease-of-care ratings for the system were high in both groups. There was a higher incidence of nausea and pruritus in the SSTS group. Conclusion: SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals.

Analgesic Effect of Aspirin, Mefenamic Acid and Their Combination in Post-Operative Oral Surgery Pain

1988 ◽  
Vol 16 (3) ◽  
pp. 167-172 ◽  
Author(s):  
S. Or ◽  
A. Bozkurt
Keyword(s):  
Single Dose ◽  
Pain Relief ◽  
Pain Intensity ◽  
Mefenamic Acid ◽  
Analgesic Effect ◽  
Oral Surgery ◽  
Double Blind ◽  
Single Dose Study ◽  
Analgesic Effects ◽  
Dose Study

A double-blind randomized single dose study of the analgesic effects of 650 mg aspirin, 250 mg mefenamic acid, the combination of 650 mg aspirin and 250 mg mefenamic acid and placebo on 120 patients with pain following oral surgery was conducted. Patients evaluated their pain intensity and extent of pain relief at 1, 2, 3 and 4 h after drug administration. For most parameters, including the sum of the pain intensity differences and the sum of the hourly pain relief scores, each of the drugs was more effective than placebo. Aspirin–mefenamic acid in combination was more effective than both drugs alone, and aspirin and mefenamic acid alone were equally effective for most of the analgesic variables.

The efficacy, tolerability, and speed of onset of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP): A multicenter, placebo-controlled, double-blind, two-phase crossover study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9535-9535
Author(s):  
N. Y. Gabrail ◽  
A. W. Burton ◽  
E. Reyes ◽  
A. Nguyen ◽  
D. R. Taylor
Keyword(s):  
Cancer Pain ◽  
Pain Intensity ◽  
Nasal Spray ◽  
Time Course ◽  
Oral Morphine ◽  
Nasal Delivery ◽  
Intensity Difference ◽  
Double Blind ◽  
Pain Intensity Difference ◽  
Breakthrough Cancer Pain

9535 Background: Breakthrough cancer pain (BTCP) affects up to 95% of patients with cancer pain but oral fentanyl formulations do not consistently match the typical time course of BTCP, which is rapid in onset and lasts for 30–60 min. To tailor fentanyl delivery for the treatment of BTCP, a new nasal formulation of fentanyl (fentanyl pectin nasal spray [FPNS]) has been developed to provide both rapid and controlled nasal delivery of fentanyl. Methods: A randomised, placebo-controlled, double-blind (DB) study assessing the efficacy and tolerability of FPNS was conducted in 114 cancer patients experiencing 1–4 BTCP episodes/day while taking ≥60 mg/day of oral morphine (or equivalent) for cancer pain. Patients who completed a titration phase (N=83) continued to a DB phase where 10 episodes of BTCP were treated with the effective dose identified during titration (7) or placebo (3). Pain intensity (PI) was measured using an 11-point categorical scale and pain relief (PR) using a 5-point scale, both PI and PR were measured at 5, 10, 15, 45 and 60 min post-dose. The primary endpoint was the Summed Pain Intensity Difference at 30 min (SPID30min). Secondary efficacy endpoints included Pain Intensity Difference (PID) from baseline, PI and PR. Safety was assessed by adverse events (AEs) and both objective and subjective nasal assessments. Results: Compared with placebo, FPNS significantly improved mean SPID30min scores (P<0.0001) and significantly improved SPID scores as early as 10 min (P<0.05) and up to 60 min (P<0.0001). Significant differences in favour of FPNS were found in PI as early as 5 min (P<0.05). Similar benefits were also seen with PID, with a trend at 5 min (P=0.07) that was significant from 10 min onward (P<0.01). PR was significant from 10 min (P<0.001) and at all time points to 60 min (P<0.001). Only 5.3% of patients withdrew from titration due to AEs; no significant nasal effects were reported. Conclusions: FPNS provided rapid and effective analgesia in BTCP and was generally safe and well tolerated. [Table: see text]

Evaluation of topical morphine for treatment of oral mucositis in cancer patients

2020 ◽  
pp. 204946372097506
Author(s):  
Bettina Nygaard Nielsen ◽  
Susanne Molin Friis ◽  
Kjeld Schmiegelow ◽  
Steen Henneberg ◽  
Janne Rømsing
Keyword(s):  
Adverse Events ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Analgesic Effect ◽  
Morphine Consumption ◽  
Intensity Difference ◽  
Control Group ◽  
Serious Adverse Events ◽  
Pain Intensity Difference ◽  
Secondary Outcomes

Introduction: Oral mucositis is a painful side effect to chemotherapy. Orally applied opioids may offer analgesia with fewer side effects than systemic opioids. Methods: A randomized trial comparing the analgesic effect of a morphine oromucosal solution (OM) to placebo and a positive control group receiving intravenous (IV) morphine as an add-on treatment to morphine patient-controlled analgesia (PCA) in a mixed population of paediatric and adult haematology patients. All patients in the study were equipped with a morphine PCA pump and the participating patients were instructed to use this pump as an escape. Primary outcome was morphine consumption (mg/kg/hour) on the PCA pump. Secondary outcomes included pain intensity difference at rest and when performing oral hygiene, time to first PCA bolus, nutrition intake and adverse events. Findings: A total of 60 patients (38 children <18 years) were randomized. Thirty patients were allocated to morphine OM/placebo IV (group MO), 15 patients to placebo OM/morphine IV (group MI) and 15 patients to placebo OM/placebo IV (group P). The median morphine consumption in the MO group (22.7 mcg/kg/hour 95% confidence interval (CI) 19.4–29.4 mcg/kg/hour, p = 0.38) was not significantly different from the placebo group (24.6 mcg/kg/hour 95% CI 16.8–34.4 mcg/kg/hour, p = 0.44) or the MI group (13.7 mcg/kg/hour 95% CI 9.7–37.8 mcg/kg/hour). For the secondary outcomes, the analysis of summed pain intensity difference after the first, third and fourth administrations of study medication indicated a reduction in pain for the MI group compared to the P and MO groups. No serious adverse events were reported. Conclusion: The findings indicate that the analgesic effect of peripherally applied morphine is not significantly different from placebo, and parenteral opioids should continue to be the standard of care.

Analgesic Combinations with Orphenadrine in Oral Post-Surgical Pain

1979 ◽  
Vol 7 (3) ◽  
pp. 240-246 ◽  
Author(s):  
Leo Winter ◽  
Arthur Post
Keyword(s):  
Pain Relief ◽  
Pain Intensity ◽  
Analgesic Efficacy ◽  
Intensity Difference ◽  
Double Blind Study ◽  
Oral Surgical Procedures ◽  
Double Blind ◽  
Pain Intensity Difference ◽  
Surgical Pain ◽  
Study Techniques

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-

Efficacy and Safety of Acetaminophen and Naproxen in the Treatment of Tension-Type Headache. A Randomized, Double-Blind, Placebo-Controlled Trial

Cephalalgia ◽  
2002 ◽  
Vol 22 (9) ◽  
pp. 740-748 ◽  
Author(s):  
MJ Prior ◽  
KM Cooper ◽  
LG May ◽  
DL Bowen
Keyword(s):  
Pain Relief ◽  
Pain Intensity ◽  
Tension Type Headache ◽  
Controlled Study ◽  
Intensity Difference ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Maximum Pain ◽  
Type Headache

The objective of this study was to evaluate and compare the efficacy and safety of single doses of acetaminophen (paracetamol) 1000 mg and naproxen 375 mg vs. placebo over a six-hour period in the treatment of tension-type headache. The treatments were compared in a randomized, double-blind, multicentre, placebo-controlled study. Efficacy was evaluated using four standard analgesic summary endpoints (the sum of pain intensity differences from baseline, the maximum pain intensity from baseline, the sum of the pain relief scores, and the maximum pain relief score). Both acetaminophen 1000 mg and naproxen 375 mg were significantly superior to placebo ( P ≤ 0.009 and P ≤ 0.021, respectively) but not significantly different from each other ( P ≥ 0.498) for these four endpoints. For example, the mean sum of pain intensity differences from baseline was 9.14 ± 0.34 for acetaminophen 1000 mg and 8.81 ± 0.35 for naproxen 375 mg compared with 7.42 ± 0.34 for placebo. Other efficacy endpoints (percentage of responders (pain reduced to none) at two hours, onset of meaningful relief, time to use of rescue medication and subject's overall impression of study medication) showed similar trends. A significantly larger mean pain intensity difference from baseline was observed for acetaminophen 1000 mg (1.13) than for naproxen 375 mg (0.95) ( P = 0.036) at one hour after treatment. There was no significant difference among the treatment groups in the incidence of adverse events ( P = 0.730). In summary, the results of this well-controlled, double-blind study demonstrate that over-the-counter acetaminophen 1000 mg and prescription naproxen 375 mg are effective and well tolerated in the treatment of tough (moderate-to-severe) tension-type headache.

Dreierkombination (Thomapyrin®) ist wirksamer bei Kopfschmerzen als Monosubstanzen und Zweierkombination

2005 ◽  
Vol 24 (07) ◽  
pp. 626-639 ◽  
Author(s):  
V. Pfaffenrath ◽  
L. Pageler ◽  
H. Peil ◽  
B. Aicher ◽  
H. C. Diener
Keyword(s):  
Pain Intensity ◽  
Visual Analog Scale ◽  
A Priori ◽  
Intensity Difference ◽  
Visuelle Analogskala ◽  
Analog Scale ◽  
Pain Intensity Difference

ZusammenfassungDie Wirksamkeit, Sicherheit und Verträglichkeit einer Einzelgabe von zwei Tabletten der fixen Dreierkombination mit 250 mg Azetylsalizylsäure (ASS) plus 200 mg Paracetamol plus 50 mg Koffein (Thomapyrin®) gegenüber zwei Tabletten mit 500 mg ASS, oder zwei Tabletten mit 500 mg Paracetamol, oder zwei Tabletten mit 50 mg Koffein beziehungsweise Plazebo wurde in einer klinischen Studie an 1 743 Patienten geprüft, die ihre episodischen Kopfschmerzen vom Spannungstyp oder ihre Migräne mit und ohne Aura üblicherweise erfolgreich mit verschreibungsfreien Analgetika behandeln. Die Dreierkombination war im a priori definierten primären Endpunkt “Zeit bis zu 50% Schmerzreduktion” sowohl der Zweierkombination aus ASS plus Paracetamol (p = 0,0181), als auch den Monoanalgetika ASS (p = 0,0398) und Paracetamol (p = 0,0016), sowie auch der Monotherapie mit Koffein (p < 0,0001) und Plazebo (p < 0,0001) überlegen. Alle Behandlungen außer der Koffein-Monotherapie waren der Plazebobehandlung überlegen (p < 0,0001). Die überlegene Wirksamkeit der Dreierkombination gilt auch für alle sekundären Endpunkte wie beispielsweise der “Verringerung der Kopfschmerzen auf 10 mm VAS (visual analog scale = visuelle Analogskala zur Schmerzmessung), dem gewichteten % SPID (sum of pain intensity difference = aufsummierte Schmerzintensitätsdifferenz gegenüber dem Ausgangsschmerz in Prozent), dem Ausmaß der Beeinträchtigung der alltäglichen Aktivitäten und der globalen Beurteilung der Wirksamkeit durch die Patienten. Alle Behandlungen waren gut verträglich, die Inzidenz von unerwünschten Begleiterscheinungen war gering.

scholarly journals Efficacy of non-opioid analgesics to control postoperative pain: a network meta-analysis

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
John A. Carter ◽  
Libby K. Black ◽  
Dolly Sharma ◽  
Tarun Bhagnani ◽  
Jonathan S. Jahr
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Human Subjects ◽  
Meta Analysis ◽  
Opioid Analgesics ◽  
Abdominal Hysterectomy ◽  
Orthopedic Procedures ◽  
Intensity Difference ◽  
Cumulative Probability ◽  
Pain Intensity Difference

Abstract Background The aim of this network meta-analysis (NMA) was to evaluate the safety and efficacy of intravenous (IV) Meloxicam 30 mg (MIV), an investigational non-steroidal anti-inflammatory drug (NSAID), and certain other IV non-opioid analgesics for moderate-severe acute postoperative pain. Methods We searched PubMed and CENTRAL for Randomized Controlled Trials (RCT) (years 2000–2019, adult human subjects) of IV non-opioid analgesics (IV NSAIDs or IV Acetaminophen) used to treat acute pain after abdominal, hysterectomy, bunionectomy or orthopedic procedures. A Bayesian NMA was conducted in R to rank treatments based on the standardized mean differences in sum of pain intensity difference from baseline up to 24 h postoperatively (sum of pain intensity difference: SPID 24). The probability and the cumulative probability of rank for each treatment were calculated, and the surface under the cumulative ranking curve (SUCRA) was applied to distinguish treatments on the basis of their outcomes such that higher SUCRA values indicate better outcomes. The study protocol was prospectively registered with by PROSPERO (CRD42019117360). Results Out of 2313 screened studies, 27 studies with 36 comparative observations were included, producing a treatment network that included the four non-opioid IV pain medications of interest (MIV, ketorolac, acetaminophen, and ibuprofen). MIV was associated with the largest SPID 24 for all procedure categories and comparators. The SUCRA ranking table indicated that MIV had the highest probability for the most effective treatment for abdominal (89.5%), bunionectomy (100%), and hysterectomy (99.8%). MIV was associated with significantly less MME utilization versus all comparators for abdominal procedures, hysterectomy, and versus acetaminophen in orthopedic procedures. Elsewhere MME utilization outcomes for MIV were largely equivalent or nominally better than other comparators. Odds of ORADEs were significantly higher for all comparators vs MIV for orthopedic (gastrointestinal) and hysterectomy (respiratory). Conclusions MIV 30 mg may provide better pain reduction with similar or better safety compared to other approved IV non-opioid analgesics. Caution is warranted in interpreting these results as all comparisons involving MIV were indirect.

Sum of Pain Intensity Differences (Spid) in Migraine Trials. A Comment Based on Four Rizatriptan Trials

Cephalalgia ◽  
2002 ◽  
Vol 22 (8) ◽  
pp. 664-666 ◽  
Author(s):  
P Tfelt-Hansen ◽  
K McCarroll ◽  
C Lines
Keyword(s):  
Clinical Trials ◽  
Pain Intensity ◽  
Treatment Response ◽  
Outcome Measure ◽  
Intensity Difference ◽  
Pain Intensity Difference ◽  
Treatment Dose ◽  
Headache Relief ◽  
Dose Effects ◽  
Using Data

Sum of Pain Intensity Difference (SPID) is an outcome measure that summarizes treatment response over a clinically relevant period. SPID is widely reported in clinical trials of analgesics but has been little used in migraine trials. We compared SPID over 2 h with the standard migraine outcome measures of pain-free at 2 h and headache relief at 2 h using data from four published clinical trials of rizatriptan in migraine patients. In assessing treatment response (rizatriptan and sumatriptan versus placebo, rizatriptan versus sumatriptan, within-treatment dose effects), SPID usually yielded similar results to the more easily understood pain-free measure.

Efficacy and Safety of Metamizol vs. Acetylsalicylic Acid in Patients With Moderate Episodic Tension-Type Headache: A Randomized, Double-Blind, Placebo- and Active-Controlled, Multicentre Study

Cephalalgia ◽  
2001 ◽  
Vol 21 (5) ◽  
pp. 604-610 ◽  
Author(s):  
P Martínez-Martín ◽  
E Raffaelli ◽  
F Titus ◽  
J Despuig ◽  
YD Fragoso ◽  
...  
Keyword(s):  
Pain Relief ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Pain Reduction ◽  
Tension Type Headache ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Maximum Pain ◽  
Type Headache

We assessed the efficacy and safety of oral single doses of 0.5 and 1 g metamizol vs. 1 g acetylsalicylic acid (ASA) in 417 patients with moderate episodic tension-type headache included in a randomized, double-blind, placebo- and active-controlled, parallel, multicentre trial. Eligibility criteria included 18–65 years of age, history of at least two episodes of tension-type headache per month in the 3 months prior to enrolment, and successful previous pain relief with a non-opioid analgesic. Treatment arms were metamizol 0.5 g ( n = 102), metamizol 1 g ( n = 108), ASA 1 g ( n = 102) and placebo ( n = 105). The analgesic efficacy of 0.5 and 1 g metamizol vs. placebo was highly statistically significant (α: 0.025; one-sided) for sum of pain intensity differences, maximum pain intensity difference, number of patients with at least 50% pain reduction, time to 50% pain reduction, maximum pain relief and total pain relief. A trend towards an earlier onset of a more profound pain relief of 0.5 and 1 g metamizol over 1 g ASA was noticed. All medications including placebo were almost equally safe and well tolerated.

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