Pain Management in Pediatric Adenotonsillectomy

Pain Management Clinical Trial

— AZU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05928520
• Other study ID #: Alazhar University
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Al-Azhar University
• Contact: Abdelwahab Saleh, MD
• Phone: +20 122 362 1031
• Email: abdelwahabsaleh11[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

Drug:
• Tramadol 5%
Topical tramadol 5%
• Lidocaine 2%
Topical Lidocaine 2%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-tonsillectomy bleeding	Percentage of cases	Within 7 days after surgery
Secondary	Postoperative nausea and vomiting	Percentage of cases	Within 7 days after surgery
Secondary	Halitosis	Percentage of cases	Within 7 days after surgery
Secondary	Otalgia	Percentage of cases	Within 7 days after surgery
Secondary	Fever	Percentage of cases	Within 7 days after surgery
Secondary	Trismus	Percentage of cases	Within 7 days after surgery
Secondary	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
Secondary	Time to first oral fluid intake	It is measured in hours, beginning from the end of the procedure	Within the first day after surgery
Secondary	Time to first oral solid intake	It is measured in hours, beginning from the end of the surgery	Within the first day after surgery