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The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.
A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par | Experimental | 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par |
|
| 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant | Experimental | 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol. |
|
| 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill | Active Comparator | 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Procedure | 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| post tonsillectomy pain | The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used. | DAY 0 6h, 24h post-operatively and DAY 5 post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Additional pain medication needed | The percentage of the patients in group 1 and 2 that will need extra analgesia | 2 weeks post operatively |
| Pt feedback after tonsillectomy | Patient satisfaction and return to normal activity. |
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Inclusion Criteria:
Age: Between 4-10 years.
Indications of tonsillectomy such as:
Tonsillectomy by cold dissection only.
American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdurrahman samir mohamed Mr, MBBS | Contact | 01069466215 | +20 | samirabdelrahman114@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams university hospitals | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24012792 | Background | Verma RR, Sriraman R, Rana SK, Ponnanna NM, Rajendar B, Ghantasala P, Rajendra L, Matur RV, Srinivasan VA. E6 protein of human papillomavirus 16 (HPV16) expressed in Escherichia coli sans a stretch of hydrophobic amino acids, enables purification of GST-DeltaE6 in the soluble form and retains the binding ability to p53. Protein Expr Purif. 2013 Nov;92(1):41-7. doi: 10.1016/j.pep.2013.08.010. Epub 2013 Sep 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2025 | May 29, 2025 |
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3 groups
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|
| NSAIDs | Drug | 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol. |
|
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| Control (Standard treatment) | Drug | 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department. |
|
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| 2 weeks post operatively |
| Complications | Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding. | 2 weeks post operatively |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000082 | Acetaminophen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
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