Clinical trial NCT05928520: Pain Management in Pediatric Adenotonsillectomy
Official title: Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pain Management
Keywords: Topical analgesia
Lidocaine
Tramadol
Modified Visual Analogue Scale
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: modified visual analogue pain score (m-VAS)
timeFrame: "day 7" after surgery
Secondary outcomes:
measure: Post-tonsillectomy bleeding
timeFrame: Within 7 days after surgery
measure: Postoperative nausea and vomiting
timeFrame: Within 7 days after surgery
measure: Halitosis
timeFrame: Within 7 days after surgery
measure: Otalgia
timeFrame: Within 7 days after surgery
measure: Fever
timeFrame: Within 7 days after surgery
measure: Trismus
timeFrame: Within 7 days after surgery
measure: Time to first ibuprofen rescue analgesia
timeFrame: Within 7 days after surgery
measure: Time to first oral fluid intake
timeFrame: Within the first day after surgery
measure: Time to first oral solid intake
timeFrame: Within the first day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, AlAzhar University
name: Abdelwahab Saleh
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.