Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol group | Experimental | Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9% |
|
| Lidocaine group | Active Comparator | Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol 5% | Drug | Topical tramadol 5% |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-tonsillectomy bleeding | Percentage of cases | Within 7 days after surgery |
| Postoperative nausea and vomiting | Percentage of cases |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelwahab Saleh, MD | Contact | +20 122 362 1031 | abdelwahabsaleh11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abdelwahab Saleh | Faculty of Medicine, AlAzhar University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30921525 | Background | Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917. | |
| 33201518 |
Not provided
Not provided
All individual participant data will be available indefinitely following publication. Data related to the study protocol, informed consent, clinical study report and the statistical analysis plan will be available to anyone who wishes to access the data.
Immediately following publication and no end date.
Data will be available indefinitely following publication. Documents will be allowed for sharing through email. A third party will decide the quality and type of data requests. The criteria for reviewing requests based on the quality of the requests.
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine 2% | Drug | Topical Lidocaine 2% |
|
|
| 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 |
| Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |