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AZU: Pain Management in Pediatric Adenotonsillectomy

Sponsor
Al-Azhar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928520
Collaborator
(none)
80
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tramadol 5%
  • Drug: Lidocaine 2%
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. modified visual analogue pain score (m-VAS) ["day 7" after surgery]

      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.

    Secondary Outcome Measures

    1. Post-tonsillectomy bleeding [Within 7 days after surgery]

      Percentage of cases

    2. Postoperative nausea and vomiting [Within 7 days after surgery]

      Percentage of cases

    3. Halitosis [Within 7 days after surgery]

      Percentage of cases

    4. Otalgia [Within 7 days after surgery]

      Percentage of cases

    5. Fever [Within 7 days after surgery]

      Percentage of cases

    6. Trismus [Within 7 days after surgery]

      Percentage of cases

    7. Time to first ibuprofen rescue analgesia [Within 7 days after surgery]

      The time from the end of the surgical procedure to the first request of ibuprofen in minutes

    8. Time to first oral fluid intake [Within the first day after surgery]

      It is measured in hours, beginning from the end of the procedure

    9. Time to first oral solid intake [Within the first day after surgery]

      It is measured in hours, beginning from the end of the surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    • Principal Investigator: Abdelwahab Saleh, Faculty of Medicine, AlAzhar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdelwahab Saleh, Professor of Anesthesia, Intensive Care, and Pain Management, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT05928520
    Other Study ID Numbers:
    • Alazhar University
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdelwahab Saleh, Professor of Anesthesia, Intensive Care, and Pain Management, Al-Azhar University
    Topical analgesia
    Lidocaine
    Tramadol
    Modified Visual Analogue Scale
    Additional relevant MeSH terms:
    Lidocaine
    Tramadol

    Study Results

    No Results Posted as of Jul 11, 2023