Pain Management in Pediatric Adenotonsillectomy

Study Overview
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Brief Summary
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Tonsillectomy is considered one of the most frequent minor surgeries conducted on a day-case basis on children, and usually associated with pain and sore throat. This study aimed to include 80 children, ASA physical status I&II aged 4-15 years, and undergoing tonsillectomy. The purpose of this study is to determine the analgesic efficacy of topically applied lidocaine and tramadol in relieving post-operative pain in children following tonsillectomy.

Detailed Description
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Pain and sore throat following tonsillectomy are typical. As a result, the issue of adequate post-tonsillectomy pain management remains a significant therapeutic obstacle. Several medications, including nonsteroidal anti-inflammatory drugs, corticosteroids and narcotics have been utilised to alleviate pain following tonsillectomy. Nevertheless, they have numerous undesirable negative consequences. NSAIDs may impede hemostasis and increase the propensity for bleeding. Opioid may result in respiratory depression, nausea, and vomiting. Consequently, the major purpose of this study is pain alleviation with minimal adverse effects. This prospective, randomized, double-blind controlled clinical study will include 80 children, undergoing tonsillectomy, to receive either topical tramadol 5% or lidocaine 2%. Modified Visual Analogue Scale (m-VAS), bleeding, nausea, vomiting, sore throat, otalgia, fever, halitosis, and constipation will be recorded.

Official Title
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Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Tramadol 5%
* Drug: Lidocaine 2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent acute tonsillitis Chronic tonsillitis Tonsillar hypertrophy with or without obstructive sleep apnea Exclusion Criteria: Parent refusal Hypersensitivity History of bronchial asthma Renal impairment Impaired liver function Bleeding disorders

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol group<br>Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9% | Drug: Tramadol 5%<br>* Topical tramadol 5%<br>* Other names: Topical tramadol;Drug: Lidocaine 2%<br>* Topical Lidocaine 2%<br>* Other names: Topical Lidocaine;|
| Active Comparator: Lidocaine group<br>Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9% | Drug: Tramadol 5%<br>* Topical tramadol 5%<br>* Other names: Topical tramadol;Drug: Lidocaine 2%<br>* Topical Lidocaine 2%<br>* Other names: Topical Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified visual analogue pain score (m-VAS) | It is 0-10 scale, color-coded (blue to red) scale. The scale also included depictions of faces, from happy to sad. Zero indicates no pain, 1-3 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe agony. | day 7 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-tonsillectomy bleeding | Percentage of cases | Within 7 days after surgery | 
| Postoperative nausea and vomiting | Percentage of cases | Within 7 days after surgery | 
| Halitosis | Percentage of cases | Within 7 days after surgery | 
| Otalgia | Percentage of cases | Within 7 days after surgery | 
| Fever | Percentage of cases | Within 7 days after surgery | 
| Trismus | Percentage of cases | Within 7 days after surgery | 
| Time to first ibuprofen rescue analgesia | The time from the end of the surgical procedure to the first request of ibuprofen in minutes | Within 7 days after surgery | 
| Time to first oral fluid intake | It is measured in hours, beginning from the end of the procedure | Within the first day after surgery | 
| Time to first oral solid intake | It is measured in hours, beginning from the end of the surgery | Within the first day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical analgesia, Lidocaine, Tramadol, Modified Visual Analogue Scale