Post Tonsillectomy PainPhase 1/2NCT05109416
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children
A Phase 1/2 study testing Bupivacaine Hydrochloride 0.5% Injection Solution and Saline 0.9% in people with Post Tonsillectomy Pain, run by Minia University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Post Tonsillectomy Pain
- What is being tested?
- Bupivacaine Hydrochloride 0.5% Injection Solution and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2021to 22 Mar 2022
- Phase
- Phase 1/2
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- average weight is 10_50 kg
- patient is generally stable
- indication of tonsillectomy is recurrent tonsillitis
- Ability to self report pain
Who cannot join
- Hypersensitivity to bupivacaine
- Obstructive sleep apnea syndrome
- Pulmonary or cardic diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .
The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .
This is prospective , double blinded , randomized study
- Conditions
- Post Tonsillectomy Pain
- Being tested
- Bupivacaine Hydrochloride 0.5% Injection Solution, Saline 0.9%
- Keywords
- Glossopharyngeal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 0.5% Injection SolutionDrug
Also called Marcaine
Local anesthetic
Saline 0.9%Drug
Also called Saline 0.9 %
Isotonic crystaloid
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first call for analgesia
Pain assessment using VAS scale
Measured: In 24 hours
Secondary outcomes (1)
The analgesic consumption
The total analgesic consumption for pain rest and swallowing
Measured: In 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start17 Oct 2021
- Primary completion5 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Tonsillectomy PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, basem saed abdalla, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109416
- Sponsor's protocol ID
- 59:4/2021
- Status last verified
- Apr 2022
- First submitted
- 29 Oct 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children
- ClinicalTrials.gov ID
- NCT05109416
- Acronym / sponsor ID
- 59:4/2021
- Conditions
- Post Tonsillectomy Pain
- Keywords
- Glossopharyngeal nerve block
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .
The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .
This is prospective , double blinded , randomized study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Bupivacaine Hydrochloride 0.5% Injection SolutionChildren will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve |
| Group B | Placebo comparator | Drug: Saline 0.9%Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- average weight is 10_50 kg
- patient is generally stable
- indication of tonsillectomy is recurrent tonsillitis
- Ability to self report pain
Key exclusion criteria (3 listed)
- Hypersensitivity to bupivacaine
- Obstructive sleep apnea syndrome
- Pulmonary or cardic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Hydrochloride 0.5% Injection SolutionAlso: MarcaineLocal anesthetic | Drug | Group A |
| Saline 0.9%Also: Saline 0.9 %Isotonic crystaloid | Drug | Group B |
Primary outcome
The first call for analgesia
Time frame: In 24 hours
Pain assessment using VAS scale
1 secondary outcome
The analgesic consumption
Time frame: In 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Post Tonsillectomy Pain
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Enrolling by invitationObservational study
Fasting Time and Post-tonsillectomy Pain
Tonsillar Disorder
Not yet recruitingPhase 4
Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
Postoperative Pain, Tonsillectomy
Not yet recruitingPhase 4
Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children
Post-tonsillectomy Pain, Tonsillectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupivacaine Hydrochloride 0.5% Injection Solution and Saline 0.9% in people with Post Tonsillectomy Pain, run by Minia University at 1 site in Egypt.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first call for analgesia (time frame: In 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.