Pain Management in Pediatric Adenotonsillectomy (AZU)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: Tramadol 5%; Drug: Lidocaine 2%

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Abdelwahab Saleh, MD; Phone Number: +20 122 362 1031; Email: abdelwahabsaleh11@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tramadol group; Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%	Drug: Tramadol 5%; Topical tramadol 5%; Other Names: Topical tramadol; Drug: Lidocaine 2%; Topical Lidocaine 2%; Other Names: Topical Lidocaine
Active Comparator: Lidocaine group; Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%	Drug: Tramadol 5%; Topical tramadol 5%; Other Names: Topical tramadol; Drug: Lidocaine 2%; Topical Lidocaine 2%; Other Names: Topical Lidocaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Abdelwahab Saleh, Faculty of Medicine, AlAzhar University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Lidocaine; Tramadol; Topical analgesia; Modified Visual Analogue Scale
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tramadol
• Other Study ID Numbers: Alazhar University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Immediately following publication and no end date.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No