Post-tonsillectomy AnalgesiaPhase 1/2NCT04113720
Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
A Phase 1/2 study testing Levobupivacaine hydrochloride and Levobupivacaine Hydrochloride + Dexmedetomidine in people with Post-tonsillectomy Analgesia and Levobupivacaine, run by Assiut University at 1 site in Egypt.
Trial summary
Tonsillectomy is one of the most common surgical performed procedures in children. Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Post-tonsillectomy Analgesia, Levobupivacaine
- What is being tested?
- Levobupivacaine hydrochloride and Levobupivacaine Hydrochloride + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2019to 30 Nov 2020
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight: 10-40 kg
- American Society of Anesthesiologists ASA physical status: I-II.
- Operation: elective tonsillectomy (±adenoidectomy) in the otorhinolaryngology department, Assuit University Hospitals due to recurrent or chronic tonsillitis with or without adenoidectomy (using the surgical retraction and bipolar diathermy if indicated).
Who cannot join
- Patients having known hypersensitivity to dexmedetomidine or levobupivacaine.
- Patients with the following conditions: obstructive sleep apnea syndrome (whether confirmed by a polysomnography test or not), previous peritonsillar abscess formation and those with swallowing disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Levobupivacaine Versus Levobupivacaine Plus Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
Tonsillectomy is one of the most common surgical performed procedures in children. Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. Postoperative throat pain is a very important and significant problem because it can lead to decreased oral intake and dehydration with subsequent serious complications of dehydration.
Read the detailed description
The idea behind the use of local anesthetic agents in the peri-operative period is not only related to its ability to block peripheral nociceptor transmission after tissue damage but also in preventing sensitization of the central nervous system. Levobupivacaine is new, long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and neurotoxic. However, few studies showed that local infiltration of levobupivacaine reduces the intensity of postoperative pain. Dexmedetomidine is a highly selective α2-adrenoceptor agonist recently introduced to anesthesia practice producing dose-dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. Dexmedetomidine is being used off-label as an adjunctive agent in pediatric patients for sedation and analgesia; in the critical care unit, during non-invasive ( Magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy). It may also decrease opioid usage and anesthesia requirements as seen from adult data prevent emergence delirium and postanesthesia shivering.
- Conditions
- Post-tonsillectomy Analgesia, Levobupivacaine
- Being tested
- Levobupivacaine hydrochloride, Levobupivacaine Hydrochloride + Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine hydrochlorideDrug
Also called levobupivacaine
levobupivacaine 0.25%
Levobupivacaine Hydrochloride + DexmedetomidineDrug
Also called levobupivacaine + precedex
Levobupivacaine plus Dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | children will receive levobupivacaine 0.25% by peritonsillar infiltration after intubation 3- 5 min before the start of surgery. Receives: Drug: Levobupivacaine hydrochloride |
| Group B | Active comparator | children will receive levobupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in 4 ml saline 0.9% and given by peritonsillar infiltration (2 ml per tonsil), after intubation 3- 5 min before the start of surgery. Receives: Drug: Levobupivacaine Hydrochloride + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first call for rescue analgesia
pain assessment using the CHEOPS scale
Measured: in 24 hours.
Secondary outcomes (2)
The analgesics consumption
The total analgesics consumption
Measured: in 24 hours.
parental satisfaction
a five-point Likert scale (1 - very dissatisfied, 2 - dissatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start15 Nov 2019
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-tonsillectomy AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113720
- Sponsor's protocol ID
- 17300316
- Status last verified
- Nov 2021
- First submitted
- 1 Oct 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akoglu E, Akkurt BC, Inanoglu K, Okuyucu S, Dagli S. Ropivacaine compared to bupivacaine for post-tonsillectomy pain relief in children: a randomized controlled study. Int J Pediatr Otorhinolaryngol. 2006 Jul;70(7):1169-73. doi: 10.1016/j.ijporl.2005.12.001. Epub 2006 Jan 18.
PubMed 16414124Arbin L, Enlund M, Knutsson J. Post-tonsillectomy pain after using bipolar diathermy scissors or the harmonic scalpel: a randomised blinded study. Eur Arch Otorhinolaryngol. 2017 May;274(5):2281-2285. doi: 10.1007/s00405-017-4451-9. Epub 2017 Feb 17.
PubMed 28213775Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. doi: 10.1111/j.1460-9592.2006.02100.x.
PubMed 17359402Karaaslan K, Yilmaz F, Gulcu N, Sarpkaya A, Colak C, Kocoglu H. The effects of levobupivacaine versus levobupivacaine plus magnesium infiltration on postoperative analgesia and laryngospasm in pediatric tonsillectomy patients. Int J Pediatr Otorhinolaryngol. 2008 May;72(5):675-81. doi: 10.1016/j.ijporl.2008.01.029. Epub 2008 Mar 5.
PubMed 18325601
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Levobupivacaine Versus Levobupivacaine Plus Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04113720
- Acronym / sponsor ID
- 17300316
- Conditions
- Post-tonsillectomy Analgesia, Levobupivacaine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Oct 2019 (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 the most common surgical performed procedures in children. Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. Postoperative throat pain is a very important and significant problem because it can lead to decreased oral intake and dehydration with subsequent serious complications of dehydration.
Detailed description
The idea behind the use of local anesthetic agents in the peri-operative period is not only related to its ability to block peripheral nociceptor transmission after tissue damage but also in preventing sensitization of the central nervous system. Levobupivacaine is new, long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and neurotoxic. However, few studies showed that local infiltration of levobupivacaine reduces the intensity of postoperative pain. Dexmedetomidine is a highly selective α2-adrenoceptor agonist recently introduced to anesthesia practice producing dose-dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. Dexmedetomidine is being used off-label as an adjunctive agent in pediatric patients for sedation and analgesia; in the critical care unit, during non-invasive ( Magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy). It may also decrease opioid usage and anesthesia requirements as seen from adult data prevent emergence delirium and postanesthesia shivering.
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 | Experimental | Drug: Levobupivacaine hydrochloridechildren will receive levobupivacaine 0.25% by peritonsillar infiltration after intubation 3- 5 min before the start of surgery. |
| Group B | Active comparator | Drug: Levobupivacaine Hydrochloride + Dexmedetomidinechildren will receive levobupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in 4 ml saline 0.9% and given by peritonsillar infiltration (2 ml per tonsil), after intubation 3- 5 min before the start of surgery. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Weight: 10-40 kg
- American Society of Anesthesiologists ASA physical status: I-II.
- Operation: elective tonsillectomy (±adenoidectomy) in the otorhinolaryngology department, Assuit University Hospitals due to recurrent or chronic tonsillitis with or without adenoidectomy (using the surgical retraction and bipolar diathermy if indicated).
Key exclusion criteria (2 listed)
- Patients having known hypersensitivity to dexmedetomidine or levobupivacaine.
- Patients with the following conditions: obstructive sleep apnea syndrome (whether confirmed by a polysomnography test or not), previous peritonsillar abscess formation and those with swallowing disorders.
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 |
|---|---|---|
| Levobupivacaine hydrochlorideAlso: levobupivacainelevobupivacaine 0.25% | Drug | Group A |
| Levobupivacaine Hydrochloride + DexmedetomidineAlso: levobupivacaine + precedexLevobupivacaine plus Dexmedetomidine | Drug | Group B |
Primary outcome
the first call for rescue analgesia
Time frame: in 24 hours.
pain assessment using the CHEOPS scale
2 secondary outcomes
The analgesics consumption
Time frame: in 24 hours.
parental satisfaction
Time frame: 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 Nov 2021.
- Background: PubMed 16414124Akoglu E, Akkurt BC, Inanoglu K, Okuyucu S, Dagli S. Ropivacaine compared to bupivacaine for post-tonsillectomy pain relief in children: a randomized controlled study. Int J Pediatr Otorhinolaryngol. 2006 Jul;70(7):1169-73. doi: 10.1016/j.ijporl.2005.12.001. Epub 2006 Jan 18.
- Background: PubMed 28213775Arbin L, Enlund M, Knutsson J. Post-tonsillectomy pain after using bipolar diathermy scissors or the harmonic scalpel: a randomised blinded study. Eur Arch Otorhinolaryngol. 2017 May;274(5):2281-2285. doi: 10.1007/s00405-017-4451-9. Epub 2017 Feb 17.
- Background: PubMed 17359402Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. doi: 10.1111/j.1460-9592.2006.02100.x.
- Background: PubMed 18325601Karaaslan K, Yilmaz F, Gulcu N, Sarpkaya A, Colak C, Kocoglu H. The effects of levobupivacaine versus levobupivacaine plus magnesium infiltration on postoperative analgesia and laryngospasm in pediatric tonsillectomy patients. Int J Pediatr Otorhinolaryngol. 2008 May;72(5):675-81. doi: 10.1016/j.ijporl.2008.01.029. Epub 2008 Mar 5.
- Individual participant dataSharing planned: No
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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.
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 Levobupivacaine hydrochloride and Levobupivacaine Hydrochloride + Dexmedetomidine in people with Post-tonsillectomy Analgesia and Levobupivacaine, run by Assiut 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 3 inclusion and 2 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 Nov 2021. 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 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 rescue 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?
On the ClinicalTrials.gov record for NCT04113720, which also lists 4 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 22 Nov 2021.