TonsillitisNCT02848287
Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children
A study testing normal saline and ropivacaine in people with Tonsillitis, run by Ajou University School of Medicine.
Trial summary
Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- normal saline and ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of anesthesiologist physical status class I/II
- tonsillectomy or adenotonsillectomy under general anesthesia
Who cannot join
- obstructive sleep apnea
- developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.
Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.
- Conditions
- Tonsillitis
- Being tested
- normal saline, ropivacaine
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
ropivacaineDrug
1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | 1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed. Receives: Drug: normal saline |
| Ropivacaine | Experimental | 1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed. Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
PAED score is assessed
Measured: 1 min after postanesthesia care unit (PACU) admission
Secondary outcomes (7)
Face legs activity cry consolability (FLACC) score
FLACC score is assessed.
Measured: 1 min after postanesthesia care unit (PACU) admission
PAED score 10 min after PACU admission
Measured: 10 min after postanesthesia care unit (PACU) admission
PAED score 20 min after PACU admission
Measured: 20 min after postanesthesia care unit (PACU) admission
PAED score 30 min after PACU admission
Measured: 30 min after postanesthesia care unit (PACU) admission
FLACC score 10 min after PACU admission
Measured: 10 min after postanesthesia care unit (PACU) admission
FLACC score 20 min after PACU admission
Measured: 20 min after postanesthesia care unit (PACU) admission
FLACC score 30 min after PACU admission
Measured: 30 min after postanesthesia care unit (PACU) admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848287
- Sponsor's protocol ID
- AJIRB-MED-DRU-16-061
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT02848287
- Acronym / sponsor ID
- AJIRB-MED-DRU-16-061
- Conditions
- Tonsillitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.
Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: normal saline1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed. |
| Ropivacaine | Experimental | Drug: ropivacaine1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of anesthesiologist physical status class I/II
- tonsillectomy or adenotonsillectomy under general anesthesia
Key exclusion criteria (2 listed)
- obstructive sleep apnea
- developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
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 |
|---|---|---|
| normal saline1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed. | Drug | Normal Saline |
| ropivacaine1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed. | Drug | Ropivacaine |
Primary outcome
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
Time frame: 1 min after postanesthesia care unit (PACU) admission
PAED score is assessed
7 secondary outcomes
Face legs activity cry consolability (FLACC) score
Time frame: 1 min after postanesthesia care unit (PACU) admission
PAED score 10 min after PACU admission
Time frame: 10 min after postanesthesia care unit (PACU) admission
PAED score 20 min after PACU admission
Time frame: 20 min after postanesthesia care unit (PACU) admission
PAED score 30 min after PACU admission
Time frame: 30 min after postanesthesia care unit (PACU) admission
FLACC score 10 min after PACU admission
Time frame: 10 min after postanesthesia care unit (PACU) admission
FLACC score 20 min after PACU admission
Time frame: 20 min after postanesthesia care unit (PACU) admission
FLACC score 30 min after PACU admission
Time frame: 30 min after postanesthesia care unit (PACU) admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline and ropivacaine in people with Tonsillitis, run by Ajou University School of Medicine.
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 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: status not confirmed, as of the sponsor's last update on 28 Jul 2016. 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. 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.
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 Go Un Roh, MD (82-31-219-6435, gone7968@aumc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission (time frame: 1 min after postanesthesia care unit (PACU) admission). 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 28 Jul 2016.