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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004181-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
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The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator |
|
|
| Placebo | Placebo Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Painscore during mobilization | Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time. | 2-24 hours after extubation time. |
| Measure | Description | Time Frame |
|---|---|---|
| Painscore during rest | Painscore during rest (VAS scale) at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time. | 2-24 hours after extubation time |
| Morphine consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikke Soennichsen, MD | Glostrup University Hospital | Principal Investigator |
| Joergen B Dahl, MD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup University Hospital | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27852230 | Derived | Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z. | |
| 26270586 | Derived | Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D009020 | Morphine |
| D017294 | Ondansetron |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Other | Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation |
|
| Morphine | Drug | Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. |
|
| Zofran | Drug | Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed |
|
| Paracetamol | Drug | Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. |
|
| Ibuprofen | Drug | Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. |
|
Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).
| 0-24 hours after extubation time. |
| Painscore during rest and mobilization | Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time. | 48 hours after extubation time |
| Degree of nausea | Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time | 2, 4, 8, 12, 24 and 48 hours after extubation time |
| Incidence of vomiting | Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time. | 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time. |
| Zofran consumption | Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time. | 0-24 and 24-48 hours after extubation time. |
| Degree of sedation | Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time. | 2, 4, 8, 12, 24 and 48 hours after extubation time. |
| Quality of sleep | Quality of sleep 24 hours after extubation time. | 24 hours after extubation time. |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |