Pain Management in Pediatric Adenotonsillectomy

NCT ID: NCT05928520

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-10-01

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.

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tramadol group

Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%

Group Type: EXPERIMENTAL

Tramadol 5%

Intervention Type: DRUG

Topical tramadol 5%

Lidocaine 2%

Intervention Type: DRUG

Topical Lidocaine 2%

Lidocaine group

Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%

Group Type: ACTIVE_COMPARATOR

Tramadol 5%

Intervention Type: DRUG

Topical tramadol 5%

Lidocaine 2%

Intervention Type: DRUG

Topical Lidocaine 2%

Interventions

Tramadol 5%

Topical tramadol 5%

Intervention Type: DRUG

Lidocaine 2%

Topical Lidocaine 2%

Intervention Type: DRUG

Other Intervention Names

Topical tramadol; Topical Lidocaine

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Abdelwahab Saleh

Professor of Anesthesia, Intensive Care, and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelwahab Saleh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, AlAzhar University

Central Contacts

Abdelwahab Saleh, MD

Role: CONTACT

abdelwahabsaleh11@gmail.com

+20 122 362 1031

References

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.

Reference Type: BACKGROUND

PMID: 30921525 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33201518 (View on PubMed)

Other Identifiers

Alazhar University

Identifier Type: -

Identifier Source: org_study_id