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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Topical tramadol 5%
Topical Lidocaine 2%
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.
Time frame: "day 7" after surgery
Post-tonsillectomy bleeding
Percentage of cases
Time frame: Within 7 days after surgery
Postoperative nausea and vomiting
Percentage of cases
Time frame: Within 7 days after surgery
Halitosis
Percentage of cases
Time frame: Within 7 days after surgery
Otalgia
Percentage of cases
Time frame: Within 7 days after surgery
Fever
Percentage of cases
Time frame: Within 7 days after surgery
Trismus
Percentage of cases
Time frame: 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
Time frame: Within 7 days after surgery
Time to first oral fluid intake
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It is measured in hours, beginning from the end of the procedure
Time frame: Within the first day after surgery
Time to first oral solid intake
It is measured in hours, beginning from the end of the surgery
Time frame: Within the first day after surgery