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ENT surgery stopped at the recruiting hospital
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Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
We will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. Outcomes include amount of morphine and ketobemidone used, and pain measured on a VAS scale. Side-effects, e.g., PONV, dizziness and sedation are also measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol | Placebo Comparator | Oral paracetamol 1 g + placebo + placebo |
|
| Paracetamol + Pregabalin | Experimental | Oral paracetamol 1g + oral pregabalin 300 mg + placebo |
|
| Paracetamol + pregabalin + dexamethasone | Experimental | Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol + placebo + placebo | Drug | Comparing the analgesic effect of combinations of paracetamol + placebo + placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (VAS) 2, 4, and 24 hours postoperatively. | 0-24 hours | |
| Both at rest and when swallowing 50 ml of water. | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of morphine and ketobemidone used 0-24 hours postoperatively. | 0-24 hours | |
| Nausea and vomiting 2, 4, and 24 hours postoperatively. | 0-24 hours | |
| Dizziness and sedation 2, 4, and 24 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole Mathiesen, MD | Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Day Case Surgery at Glostrup University Hospital | Glostrup Municipality | 2600 | Denmark |
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| paracetamol + pregabalin + placebo | Drug | Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo |
|
|
| paracetamol + pregabalin + dexamethasone | Drug | Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg |
|
|
| 0-24 hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000069583 | Pregabalin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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