Paracetamol 500mg / Metoclopramide 5mg tablets
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Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-medi…
Affected areas: UK
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Headaches in over 12s: diagnosis and management (CG150)
Type 1 diabetes in adults: diagnosis and management (NG17)
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Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing all 19 studies.
Reviews & meta-analyses: 1 · Randomised trials: 3 · 2023–2026
Showing all 19 studies, sorted by most relevant.
Roberts E, Kalk N, Strang J
2026
- Analgesics, Opioid
- Buprenorphine
- Narcotic Antagonists
BACKGROUND AND AIMS: There has been limited evidence synthesis examining the treatment of buprenorphine precipitated opioid withdrawal (BPOW). We aimed to conduct the first systematic review to assess the clinical utility of any pharmacological intervention in the management of BPOW. METHODS: Systematic review searching Medline, Embase, PsychINFO and CENTRAL from the date of database inception to 26 August 2025 for studies of any design reporting any pharmacological intervention in the management of BPOW compared with any or no other interventions, using adult participants aged 18 or over receiving buprenorphine and experiencing BPOW. We planned to combine outcomes using random-effects meta-analysis; where this was not possible results were reported narratively. We considered two outcomes and extracted (1) any reported measure or description of the change in opioid withdrawal symptoms (OWS) and (2) the number of individuals retained in buprenorphine treatment. Outcome quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. RESULTS: Forty-three studies met inclusion criteria reporting on 137 participants. These comprised one pilot randomised controlled trial and 42 uncontrolled observational case series or case reports. Meta-analysis was not possible, and all evidence was of low or very low quality. The currently available randomised evidence suggests that use of intravenous magnesium sulphate, in addition to symptomatic treatment with clonidine, paracetamol and diazepam, may statistically significantly reduce OWS when compared with symptomatic treatment alone. The currently available observational evidence suggests that treatment strategies which include additional doses of transmucosal buprenorphine may demonstrate higher rates of symptom control and treatment retention than strategies which do not include additional doses of transmucosal buprenorphine. CONCLUSIONS: There is a paucity of research into pharmacological management of buprenorphine precipitated opioid withdrawal. The limited very low to low quality evidence suggests treatment regimens that include magnesium sulphate and additional doses of transmucosal buprenorphine are potentially the most salient current options and avenues for future research in the management of buprenorphine precipitated opioid withdrawal.
Abstract licence: CC BY
Tamayo de Leon CD, Gama-Reyes EG, Paredes Moreno FA, et al.
2025
- Migraine Disorders
- Acetaminophen
- Anesthetics, Local
Aim To evaluate the efficacy and safety of greater occipital nerve (GON) block combined with triple therapy versus triple therapy alone in the treatment of acute migraine in the emergency department for severe or refractory cases setting. Methods We conducted a prospective, randomized, controlled trial without use of placebo control in adult patients with migraine according to International Classification of Headache Disorders, 3rd editon criteria. Patients were randomly assigned (1:1), without blinding method, to receive either a GON block (methylprednisolone 80 mg + lidocaine 20 mg) plus triple intravenous therapy (ketorolac, paracetamol, metoclopramide) or triple therapy alone. The primary outcome was the proportion of patients achieving ≥50% reduction in headache intensity on a visual analog scale (VAS) two hours post-treatment. Secondary outcomes included changes in monthly migraine days, pain-free days, Headache Impact Test-6 (HIT-6) scores and hospital readmissions at 30-day follow-up. Results Forty-two patients were enrolled (21 per group). A ≥50% VAS reduction at two hours occurred in 95.2% of patients receiving the GON block versus 47.6% in the control group ( p = 0.0003). Median pain reduction was 6.0 vs. 3.0 points, respectively ( p < 0.001). At 30 days, the intervention group reported fewer migraine days (median 3.0 vs. 7.0 days; p = 0.0355), more pain-free days (14.0 vs. 5.0 days; p = 0.0379) and lower HIT-6 scores (59.0 vs. 65.0; p = 0.1584). Readmission rates were lower in the intervention group (9.5% vs. 23.8%) but not statistically significant. Adverse events associated with the GON block were mild and transient, including local pain (47.6%) and minor bleeding (14.3%). Conclusions GON block as an adjunct to triple therapy is effective and well tolerated for the acute treatment of migraine, providing significant short-term relief and improving outcomes at 30-day follow-up. Our failure to blind the outcome assessors limit the validity of our results, which supports the use of GON block as an adjunct to parenteral therapy for patients with migraine in the emergency department. Trial Registration This study was not registered in a public trial registry.
Abstract licence: CC BY-NC
Cebeci K, Akesen S, Cansabuncu S, et al.
2026
During laparoscopic gynecological surgeries, trocar incisions, pneumoperitoneum and distention of the anterior abdominal wall can cause postoperative pain. Inadequate pain management can increase the risk of postoperative complications. The present study compared the effects of oblique subcostal transversus abdominis plane (OSTAP) block and transmuscular quadratus lumborum (TQL) block on postoperative analgesia and quality of recovery (QoR) in patients undergoing laparoscopic gynecological surgery. A total of 73 patients were enrolled in this prospective, randomized, controlled, double-blind study. The patients were randomly allocated to the OSTAP group (n = 36) or the TQL group (n = 37). General anesthesia was induced following bilateral block administration with 20 ml of 0.25% bupivacaine. The primary outcome was postoperative tramadol requirement. Secondary outcomes included postoperative paracetamol requirement, time to first paracetamol and tramadol requirement, total paracetamol and tramadol consumption, visual analog scale (VAS) scores at rest and during movement, and Quality of Recovery-15 (QoR-15) scores preoperatively and 24 h postoperatively. Postoperative tramadol requirement was significantly lower in the TQL group (p = 0.006). Total paracetamol consumption was also significantly lower in the TQL group (p = 0.002). No significant between-group difference was observed in VAS scores at rest, whereas VAS scores during movement were significantly lower in the TQL group (p = 0.009). The groups were similar regarding QoR-15 scores preoperatively and 24 h postoperatively. The TQL block reduces postoperative tramadol requirements compared to the OSTAP block. However, both blocks have similar effects on QoR. ClinicalTrials.gov, NCT06017401. Registered on August 20, 2023. Retrospectively registered.
Abstract licence: CC BY-NC-ND
Sluis WM, de Jonge JC, Reinink H, et al.
2025
- Stroke
- Acetaminophen
- Ceftriaxone
INTRODUCTION: The modified Rankin Scale (mRS) is the most frequently used primary outcome measure in acute stroke research despite significant interobserver variability in assigning grades. We assessed the use of central blinded adjudication of the mRS based on a video recording of an interview in the PRECIOUS trial. PATIENTS AND METHODS: PRECIOUS was an international, randomized, open-label, clinical trial with blinded outcome assessment of preventive treatment with metoclopramide, paracetamol, and ceftriaxone in elderly patients with acute stroke. Trained local investigators interviewed patients or their representatives and graded functional outcome at 90 days after stroke with the mRS. In each participating country, a video recording of the interview was assessed by three blinded, independent adjudicators. The primary outcome of the present substudy was interobserver agreement between the local mRS score and the median score of the three central adjudicators for patients alive at 90 days, assessed with Cohen's kappa and quadratic weighted kappa statistics. The difference between treatment effect estimates based on local and central adjudication was a secondary outcome. RESULTS: Of 1493 patients enrolled in PRECIOUS, 1471 were included in this analysis. At 90 days, 1117 patients (75.9%) were alive and had both a central and local assessment; 28 participants did not have a central mRS score. Interobserver agreement was seen in 829 (74.2%) patients and was substantial (kappa of 0.68; 95% CI 0.65-0.71). Disagreement occurred more often in patients with a central mRS score of 0-2 (OR 2.24; 95% CI 1.14-4.24). Treatment effects were neutral for all three study drugs and did not differ between central and local adjudication. DISCUSSION AND CONCLUSION: Central adjudication of the mRS based on a video recording is feasible in a large international, randomized stroke trial. This ensures blinding of the outcome assessment. In this neutral trial, the impact of central adjudication on the precision of effect size estimates could not be assessed.
Abstract licence: CC BY
W. M. Sluis, Jeroen C de Jonge, Hendrik Reinink, et al.
Stroke, 2024
- Intubation, Gastrointestinal
- Acetaminophen
- Ischemic Stroke
BACKGROUND: A randomized trial suggested that treatment with metoclopramide reduces the risk of pneumonia in patients with acute stroke and a nasogastric tube. We assessed whether this finding could be replicated in a post hoc analysis of the randomized PRECIOUS trial (Prevention of Complications to Improve Outcome in Elderly Patients With Acute Stroke). METHODS: PRECIOUS was an international, 3×2 partial-factorial, randomized controlled, open-label clinical trial with blinded outcome assessment assessing preventive treatment with metoclopramide, paracetamol, and ceftriaxone in patients aged ≥66 years with acute ischemic stroke or intracerebral hemorrhage and a National Institutes of Health Stroke Scale score ≥6. In the present study, we analyzed patients who had a nasogastric tube within 24 hours after randomization. Patients who were allocated to metoclopramide (10 mg TID) were compared with patients who were not. Treatment was started within 24 hours after symptom onset and continued for 4 days or until discharge if earlier. The primary outcome was pneumonia in the first week after stroke. The score on the modified Rankin Scale after 90 days was a secondary outcome and analyzed with ordinal logistic regression. RESULTS: From April 2016 through June 2022, a total of 1493 patients were enrolled with 1376 included in this analysis, of whom 1185 (86%) had ischemic stroke and 191 (14%) had intracerebral hemorrhage. The first day after randomization, 329 (23.9%) patients had a nasogastric tube, of whom 156 were allocated to metoclopramide and 173 to standard care. Metoclopramide was not associated with a reduction of pneumonia (41.0% versus 35.8%; adjusted odds ratio, 1.35 [95% CI, 0.79-2.30]) or with poor functional outcome (adjusted odds ratio, 1.07 [95% CI, 0.71-1.61]). CONCLUSIONS: In patients with stroke who had a nasogastric tube shortly after stroke onset, metoclopramide for 4 days did not reduce pneumonia or have an effect on the functional outcome.
Abstract licence: CC BY
Kucharlapati Madhu Hasitha Devi, A. Venkateswara Rao, B. Sravanasree
International Journal of Allied Medical Sciences and Clinical Research, 2023
A new simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Paracetamol and Metoclopramide HCl, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5 µ column using a mixture of Methanol: Phosphate Buffer pH-3.6 (30:70v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Paracetamol and Metoclopramide HCl was 2.669, 3.855±0.02min respectively. The method produce linear responses in the concentration range of 10-50µg/ml of Paracetamol and 10-50µg/ml of Metoclopramide HCl. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Abstract licence: CC BY
Rekha BH, Hisham SA, Wahab IA, et al.
2024
- Adverse Drug Reaction Reporting Systems
- Drug-Related Side Effects and Adverse Reactions
- Bayes Theorem
BACKGROUND: Digital solutions can help monitor medication safety in children who are often excluded in clinical trials. The lack of reliable safety data often leads to either under- or over-dose of medications during clinical management which make them either not responding well to treatment or susceptible to adverse drug reactions (ADRs). AIM: This study investigated ADR signalling techniques to detect serious ADRs in Malaysian children aged from birth to 12 years old using an electronic ADRs' database. METHODS: Four techniques (Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS)) were tested on ADR reports submitted to the National Pharmaceutical Regulatory Agency between 2016 and 2020. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the techniques were compared. RESULTS: A total of 31 medicine-Important Medical Event pairs were found and examined among the 3152 paediatric ADR reports. Three techniques (PRR, ROR, MGPS) signalled oculogyric crisis and dystonia for metoclopramide. BCPNN and MGPS signalled angioedema for paracetamol, amoxicillin and ibuprofen. Similar performances were found for PRR, ROR and BCPNN (sensitivity of 12%, specificity of 100%, PPV of 100% and NPV of 21%). MGPS revealed the highest sensitivity (20%) and NPV (23%), as well as similar specificity and PPV (100%). CONCLUSIONS: This study suggests that medication safety signalling techniques could be applied on electronic health records to monitor medication safety issues in children. Clinicians and medication safety specialist could prioritise the signals for further clinical consideration and prompt response.
Abstract licence: CC BY-NC-ND
Reactions Weekly, 2026
Abdulsalam Nayer Alsulami, Reem Fareed Aldeijy, Elsharif A. Bazie
Open Journal of Pediatrics, 2023
Medication errors are Unlike adverse drug reactions (ADRs) or adverse drug events (ADEs); mistakes by healthcare personnel cause them. We reported two cases of developed symptoms of Metoclopramide over-dose. Metoclopramide was given as Paracetamol due to look-a-like packaging. In Emergency Departments, reviewing the patient’s medications to prevent look-a-like complications should be done for all patients with suspected drug toxicity.
Abstract licence: CC BY
Lateefa A. Al-Khateeb, Mohammed Gamal, Mohamed A. Elsayed, et al.
Scientific Reports, 2025
- Acetaminophen
- Gas Chromatography-Mass Spectrometry
- Metoclopramide
The growing demand for eco-friendly and cost-effective analytical methods has driven the development of a fast, green, and sensitive GC-MS assay for the simultaneous quantification of paracetamol (PAR) and metoclopramide (MET) in pharmaceutical formulations and human plasma. Separation was achieved in 5 min using a high-polarity 5% Phenyl Methyl Silox column, with detection at *m/z* 109 (PAR) and 86 (MET). The method was fully validated per ICH guidelines, showing excellent linearity (PAR: 0.2-80 µg/mL, r² = 0.9999; MET: 0.3-90 µg/mL, r² = 0.9988) and precision (tablet recovery: 102.87 ± 3.605% PAR, 101.98 ± 3.392% MET; plasma recovery: 92.79 ± 1.521% PAR, 91.99 ± 2.153% MET). Greenness assessment via three metrics, including the BAGI tool (score: 82.5), confirmed its environmental superiority over conventional methods. With high sensitivity, accuracy, and a 5-minute runtime, this approach is ideal for routine quality control and pharmacokinetic studies.
Abstract licence: CC BY-NC-ND
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
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