Pain Management in Pediatric Adenotonsillectomy (AZU)

Al-Azhar University

Status and phase: Not yet enrolling; Phase 3

Conditions: Pain Management

Treatments: Drug: Lidocaine 2%; Drug: Tramadol 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT05928520

Alazhar University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Tramadol group

Experimental group

Description:

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

Treatment:

Drug: Lidocaine 2%

Drug: Tramadol 5%

Lidocaine group

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine 2%

Drug: Tramadol 5%