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This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.
Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects.
This prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Paracetamol | Experimental | Participants in this arm received intranasal paracetamol (1.25 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery. |
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| Intranasal Diclofenac Sodium | Experimental | Participants in this arm received intranasal diclofenac sodium (0.0625 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery. |
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| Intranasal Ibuprofen | Experimental | Participants in this arm received intranasal ibuprofen (0.375 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery. |
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| Intravenous Paracetamol | Active Comparator | Participants in this arm received intravenous paracetamol (20 mg/kg/day, twice daily) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous paracetamol | Drug | Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Children's Hospital of Eastern Ontario Pain Scale measurements | CHEOPS consists of a total of 6 categories of behaviour, with specific score ranges for each. The total score ranges from 6 to 16. A score of 16 means a lot of pain, while 4 means no pain. | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| VISUAL ANALOGUE Scale measurements | The patient indicates the level of pain by marking it on a visual scale, with one end of the line labelled 'No Pain' (0) and the other end labelled 'Intolerable Pain' (10). 0: No pain at all. 1-3: Mild pain. 4-6: Moderate pain. 7-10: Severe pain. | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker Facial Pain Scale (Modified VAS) measurements | It is an adapted version for children. Pain is graded on the basis of different facial expressions (happy face → crying face). A happy face means no pain, while a crying face means a lot of pain. | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). |
Inclusion Criteria:
-Pediatric patients who have undergone a tonsillectomy.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramazan Bahadır KÜÇÜK | Istanbul | 34093 | Turkey (Türkiye) |
I plan to share the excel file where the results are collected and made understandable
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The period of completion of the study and data analysis 30 December 2024-15 January 2025
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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 | Dec 11, 2024 | Dec 29, 2024 |
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prospective, randomized study
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| Intranasal Paracetamol | Drug | Paracetamol at a concentration of 1.25 mg/mL was administered intranasally. |
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| Intranasal Diclofenac Sodium | Drug | Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally. |
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| Intranasal Ibuprofen | Drug | Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally. |
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| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2024 | Dec 29, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2024 | Dec 29, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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