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This pilot randomised controlled trial compared the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. The primary outcome was postoperative pain intensity measured using the Numerical Rating Scale (NRS 0-10) at recovery room arrival and at 30, 60, and 90 minutes thereafter.
Acute postoperative pain remains inadequately managed in a substantial proportion of surgical patients, with particular challenges in resource-limited settings where access to potent opioids is restricted. Cross-class equianalgesic data comparing NSAIDs with weak opioids are scarce. This single-centre, double-blind, parallel-group pilot RCT was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Thirty adult patients (ASA I-II, age 18-55 years, BMI 18.5-34.99 kg/m²) scheduled for elective laparoscopic surgery were randomised equally to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV, administered 45 minutes before skin incision. All patients received standardised balanced general anaesthesia. Pain was assessed using the NRS and Verbal Rating Scale (VRS) at five time points. Rescue analgesia (morphine 3 mg IV) was available on request. The trial was initially registered with the ISSSTE institutional research registry (RPI #403-2024).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAM | Active Comparator | Participants received tramadol 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
|
| KETO | Active Comparator | Participants received ketorolac 60 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
|
| DICLO | Active Comparator | Participants received diclofenac 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Tramadol 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). Between-group comparisons performed at each time point using Kruskal-Wallis tests with Dunn post-hoc correction. | At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival. |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical pain intensity by Verbal Rating Scale (VRS) | Pain category assessed using a four-point Verbal Rating Scale (0 = absence, 1 = low, 2 = moderate, 3 = severe). Between-group differences assessed using Pearson's chi-squared test with Cramér's V as effect size. | At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional "General Ignacio Zaragoza," ISSSTE | Mexico City | Mexico City | 09360 | Mexico |
De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).
Beginning at the time of article publication, with no end date.
Data and code will be publicly available with no access restrictions via GitHub.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D020910 | Ketorolac |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Three-arm parallel-group pilot RCT. Participants were randomised equally (n=10 per group) to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV as premedication 45 minutes before skin incision.
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Study drugs were prepared in identical 100 mL 0.9% saline bags by personnel not otherwise involved in the study and delivered unlabelled to the responsible anaesthesiologist, ensuring blinding of both the investigator and the patient.
| Ketorolac | Drug | Ketorolac 60 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. |
|
| Diclofenac | Drug | Diclofenac 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. |
|
| Rescue morphine consumption | Number of rescue analgesic doses and total morphine consumed (mg IV) per group. Rescue analgesia (morphine 3 mg IV) was administered on patient request or clinical indication. | At 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival. |
| Incidence of hypersensitivity reactions | Hypersensitivity reactions of any grade classified according to Müller criteria (Grade I-IV). Managed per institutional protocol (hydrocortisone 100 mg IV; adrenaline 0.5 mg IM for anaphylaxis). | Throughout the 90-minute observation period |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |