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Pain ManagementPhase 3AZUNCT05928520

Pain Management in Pediatric Adenotonsillectomy

A Phase 3 study testing Tramadol 5% and Lidocaine 2% in people with Pain Management, run by Al-Azhar University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 15 years
Conditions the study is for
Pain Management
What is being tested?
Tramadol 5% and Lidocaine 2%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Aug 2023to 1 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Abdelwahab Saleh, MD contact

+20 122 362 1031

abdelwahabsaleh11@gmail.com

About this study

Official title: Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy

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.

Read the 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
Being tested
Tramadol 5%, Lidocaine 2%
Keywords
Topical analgesia, Lidocaine, Tramadol, Modified Visual Analogue Scale
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tramadol 5%Drug

    Also called Topical tramadol

    Topical tramadol 5%

  • Lidocaine 2%Drug

    Also called Topical Lidocaine

    Topical Lidocaine 2%

Study groups in NCT05928520
Study groupRoleWhat they receive
Tramadol groupExperimentalSwabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%
Receives: Drug: Tramadol 5%; Drug: Lidocaine 2%
Lidocaine groupActive comparatorSwabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%
Receives: Drug: Tramadol 5%; Drug: Lidocaine 2%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: "day 7" after surgery

Secondary outcomes (9)

  1. Post-tonsillectomy bleeding

    Percentage of cases

    Measured: Within 7 days after surgery

  2. Postoperative nausea and vomiting

    Percentage of cases

    Measured: Within 7 days after surgery

  3. Halitosis

    Percentage of cases

    Measured: Within 7 days after surgery

  4. Otalgia

    Percentage of cases

    Measured: Within 7 days after surgery

  5. Fever

    Percentage of cases

    Measured: Within 7 days after surgery

  6. Trismus

    Percentage of cases

    Measured: Within 7 days after surgery

  7. Time to first ibuprofen rescue analgesia

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

    Measured: Within 7 days after surgery

  8. Time to first oral fluid intake

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

    Measured: Within the first day after surgery

  9. Time to first oral solid intake

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

    Measured: Within the first day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928520
Sponsor's protocol ID
Alazhar University
Acronym
AZU
Status last verified
Jul 2023
First submitted
1 Jun 2023
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30921525

  • 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.

    PubMed 33201518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tramadol 5% and Lidocaine 2% in people with Pain Management, run by Al-Azhar University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abdelwahab Saleh, MD (+20 122 362 1031, abdelwahabsaleh11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified visual analogue pain score (m-VAS) (time frame: "day 7" after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05928520, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.

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