Pain Management in Pediatric Adenotonsillectomy
- Registration Number
- NCT05928520
- Lead Sponsor
- Al-Azhar University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Recurrent acute tonsillitis
- Chronic tonsillitis
- Tonsillar hypertrophy with or without obstructive sleep apnea
- Parent refusal
- Hypersensitivity
- History of bronchial asthma
- Renal impairment
- Impaired liver function
- Bleeding disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine group Lidocaine 2% Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9% Tramadol group Tramadol 5% Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9% Tramadol group Lidocaine 2% Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9% Lidocaine group Tramadol 5% Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%
- Primary Outcome Measures
Name Time Method modified visual analogue pain score (m-VAS) "day 7" after surgery 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.
- Secondary Outcome Measures
Name Time Method Fever Within 7 days after surgery Percentage of cases
Halitosis Within 7 days after surgery Percentage of cases
Otalgia Within 7 days after surgery Percentage of cases
Trismus Within 7 days after surgery Percentage of cases
Time to first oral fluid intake Within the first day after surgery It is measured in hours, beginning from the end of the procedure
Post-tonsillectomy bleeding Within 7 days after surgery Percentage of cases
Time to first ibuprofen rescue analgesia Within 7 days after surgery The time from the end of the surgical procedure to the first request of ibuprofen in minutes
Time to first oral solid intake Within the first day after surgery It is measured in hours, beginning from the end of the surgery
Postoperative nausea and vomiting Within 7 days after surgery Percentage of cases