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The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Therefore, the present study is designed to evaluate the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum protein, C-reactive protein, and analgesic consumption after tonsillectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo group (n=30) will receive a submucosal infiltration with 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. |
|
| lidocaine | Active Comparator | will receive a total of 2 mg.kg-1 of 2% lidocaine HCl (Xylocaine, Astra-Zeneca,) in 3 mL of normal saline (1.5 ml around each tonsil), 5 minutes before surgical incision. |
|
| Tramadol | Experimental | (n=30) will receive a submucosal infiltration with 2 mg kg-1 tramadol in 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peritonsillar infiltration | Drug | 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory and stress response | CRP Acute phase protein | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic changes | MBP HR | 24 hours |
| pain score | VAS The time to first request for analgesia and the number of subjects receiving meperidine during the first 12 hours will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| laila Telmesani, MD | UD | Principal Investigator |
| Hany A. Mowafi, MD | Associate Professor | Study Chair |
| Alaa M. Khidr, MD | Assistant Consultant | Study Chair |
| Abdulhadi Al'Saflan, MD | Assistant Consultant | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dammam University KFHU | Khobar | EP | 31952 | Saudi Arabia | ||
| UD-KFHU |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| 24 hours |
| Side-effects | postoperative stridor, laryngospasm, cyanosis, bleeding, seizures, sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep); nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting), respiratory depression (ventilatory frequency 10), and desaturation (92%), at 0, 1, 2, 4, 6, 8, and 12 h after surgery. | 24 hours |
| Khobar |
| EP |
| 31952 |
| Saudi Arabia |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |