NCT05928520

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

June 1, 2023

Last Update Submit

July 9, 2023

Conditions

Pain Management

Keywords

Topical analgesiaLidocaineTramadolModified Visual Analogue Scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Post-tonsillectomy bleeding

    Within 7 days after surgery

  • Postoperative nausea and vomiting

    Within 7 days after surgery

  • Halitosis

    Within 7 days after surgery

  • Otalgia

    Within 7 days after surgery

  • Fever

    Within 7 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

Tramadol group

EXPERIMENTAL

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

Drug: Tramadol 5%Drug: Lidocaine 2%

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Tramadol 5%Drug: Lidocaine 2%

Interventions

Tramadol 5%DRUG

Topical tramadol 5%

Also known as: Topical tramadol
Lidocaine groupTramadol group
Lidocaine 2%DRUG

Topical Lidocaine 2%

Also known as: Topical Lidocaine
Lidocaine groupTramadol group

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Recurrent acute tonsillitis
  • Chronic tonsillitis
  • Tonsillar hypertrophy with or without obstructive sleep apnea

You may not qualify if:

  • Parent refusal
  • Hypersensitivity
  • History of bronchial asthma
  • Renal impairment
  • Impaired liver function
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 30921525BACKGROUND

  • 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.

    PMID: 33201518BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

TramadolLidocaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • Abdelwahab Saleh

    Faculty of Medicine, AlAzhar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab Saleh, MD

CONTACT

+20 122 362 1031abdelwahabsaleh11@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia, Intensive Care, and Pain Management

Study Record Dates

First Submitted

June 1, 2023

First Posted

July 3, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

All individual participant data will be available indefinitely following publication. Data related to the study protocol, informed consent, clinical study report and the statistical analysis plan will be available to anyone who wishes to access the data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication and no end date.
Access Criteria
Data will be available indefinitely following publication. Documents will be allowed for sharing through email. A third party will decide the quality and type of data requests. The criteria for reviewing requests based on the quality of the requests.