Pain Management
Conditions
Keywords
Topical analgesia, Lidocaine, Tramadol, Modified Visual Analogue Scale
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.
Interventions
DRUGTramadol 5%
Topical tramadol 5%
DRUGLidocaine 2%
Topical Lidocaine 2%
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting | 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 |
| Fever | Within 7 days after surgery | Percentage of cases |
| 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 fluid intake | Within the first day after surgery | It is measured in hours, beginning from the end of the procedure |
| Time to first oral solid intake | Within the first day after surgery | It is measured in hours, beginning from the end of the surgery |
| Trismus | Within 7 days after surgery | Percentage of cases |
Contacts
Primary ContactAbdelwahab Saleh, MD
Outcome results
None listed