NCT05109416

Brief Summary

Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

October 29, 2021

Last Update Submit

April 21, 2022

Conditions

Post Tonsillectomy Pain

Keywords

Glossopharyngeal nerve block

Outcome Measures

Primary Outcomes (1)

  • The first call for analgesia

    Pain assessment using VAS scale

    In 24 hours

Secondary Outcomes (1)

  • The analgesic consumption

    In 24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve

Drug: Bupivacaine Hydrochloride 0.5% Injection Solution

Group B

PLACEBO COMPARATOR

Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches

Drug: Saline 0.9%

Interventions

Bupivacaine Hydrochloride 0.5% Injection SolutionDRUG

Local anesthetic

Also known as: Marcaine
Group A
Saline 0.9%DRUG

Isotonic crystaloid

Also known as: Saline 0.9 %
Group B

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • average weight is 10\_50 kg
  • patient is generally stable
  • indication of tonsillectomy is recurrent tonsillitis
  • Ability to self report pain

You may not qualify if:

  • Hypersensitivity to bupivacaine
  • Obstructive sleep apnea syndrome
  • Pulmonary or cardic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medcine

Minya, 61111, Egypt

Location

MeSH Terms

Interventions

BupivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 5, 2021

Study Start

October 17, 2021

Primary Completion

March 5, 2022

Study Completion

March 22, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)