Post Operative PainPhase 4NCT05341323
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
A Phase 4 study testing Ketamine. and Bupivacaine in people with Post Operative Pain, run by Sohag University at 1 site in Egypt.
Trial summary
Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ketamine. and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to 2 Jul 2022
- Phase
- Phase 4
- 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 3 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 3-20 years old patients
- elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.
Who cannot join
- allergy to bupivacaine or ketamine
- coagulopathy
- endocrine, neuropsychiatric or cardiopulmonary dysfunction
- increase intracranial pressure (ICP)
- psychiatric illness, history of seizure, patients under chronic analgesic treatment
- history of peritonsillar abscess, tonsillar malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia
- Conditions
- Post Operative Pain
- Being tested
- Ketamine., Bupivacaine
- Keywords
- Ketamine, Bupivacaine, tonsillectomy, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine.Drug
Peritonsillar infiltration of ketamine
BupivacaineDrug
peritonsillar infiltration of Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group K1 Ketamine | Active comparator | pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area Receives: Drug: Ketamine. |
| Group B1 Bupivacaine | Active comparator | pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The pain will be assessed using modified Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia
Measured: 60 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 Apr 2022
- Primary completion2 Jul 2022
- Study completion2 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Sohag 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdallah Abozaid, Sohag University
- Investigators
- Ibrahem Risk, Professor, Study director, Professor of ENTOsama Elshrief, Professor, Study chair, Dean of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341323
- Sponsor's protocol ID
- Soh_Med_22_02_07
- Status last verified
- Jul 2022
- First submitted
- 3 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
- ClinicalTrials.gov ID
- NCT05341323
- Acronym / sponsor ID
- Soh_Med_22_02_07
- Conditions
- Post Operative Pain
- Keywords
- Ketamine, Bupivacaine, tonsillectomy, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 22 Apr 2022 (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.
Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K1 Ketamine | Active comparator | Drug: Ketamine.pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area |
| Group B1 Bupivacaine | Active comparator | Drug: Bupivacainepre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area |
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 3-20 years old patients
- elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.
Key exclusion criteria (6 listed)
- allergy to bupivacaine or ketamine
- coagulopathy
- endocrine, neuropsychiatric or cardiopulmonary dysfunction
- increase intracranial pressure (ICP)
- psychiatric illness, history of seizure, patients under chronic analgesic treatment
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 |
|---|---|---|
| Ketamine.Peritonsillar infiltration of ketamine | Drug | Group K1 Ketamine |
| Bupivacaineperitonsillar infiltration of Bupivacaine | Drug | Group B1 Bupivacaine |
Primary outcome
Postoperative pain
Time frame: 60 minutes postoperatively
The pain will be assessed using modified Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia
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 19 Jul 2022.
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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.
Ibrahem Risk, Professor study director
Professor of ENT
Osama Elshrief, Professor study chair
Dean of Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine. and Bupivacaine in people with Post Operative Pain, run by Sohag 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 2 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: finished, as of the sponsor's last update on 19 Jul 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postoperative pain (time frame: 60 minutes postoperatively). 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 19 Jul 2022.