Clinical Trials Logo
  1. Home
  2. Tonsillitis
  3. NCT02848287
  4. Details
NCT02848287 Clinical Trial

Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Tonsillitis Clinical Trial

Official title:
Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02848287
Other study ID # AJIRB-MED-DRU-16-061
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 26, 2016
Last updated July 26, 2016
Start date August 2016
Est. completion date August 2017

Study information
Verified date July 2016
Source Ajou University School of Medicine
Contact Go Un Roh, MD
Phone 82-31-219-6435
Email gone7968@aumc.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical 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.

Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 84
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- American Society of anesthesiologist physical status class I/II

- tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion Criteria:

- obstructive sleep apnea

- developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• normal saline
1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
• ropivacaine
1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission PAED score is assessed 1 min after postanesthesia care unit (PACU) admission No
Secondary Face legs activity cry consolability (FLACC) score FLACC score is assessed. 1 min after postanesthesia care unit (PACU) admission No
Secondary PAED score 10 min after PACU admission 10 min after postanesthesia care unit (PACU) admission No
Secondary PAED score 20 min after PACU admission 20 min after postanesthesia care unit (PACU) admission No
Secondary PAED score 30 min after PACU admission 30 min after postanesthesia care unit (PACU) admission No
Secondary FLACC score 10 min after PACU admission 10 min after postanesthesia care unit (PACU) admission No
Secondary FLACC score 20 min after PACU admission 20 min after postanesthesia care unit (PACU) admission No
Secondary FLACC score 30 min after PACU admission 30 min after postanesthesia care unit (PACU) admission No
See also
  Status Clinical Trial Phase
Recruiting NCT04083417 - Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and no Antibiotic Treatment Phase 4
Completed NCT04551196 - Management of Post-Tonsillectomy Pain in Pediatric Patients Phase 3
Active, not recruiting NCT03654742 - Intracapsular Tonsillectomy in Adults N/A
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02712307 - Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci Phase 4
Enrolling by invitation NCT02205580 - Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children Phase 4
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Active, not recruiting NCT01691690 - Analgesic Effect of IV Acetaminophen in Tonsillectomies Phase 2
Completed NCT00393744 - Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Active, not recruiting NCT00136877 - Tonsillectomy in Recurrent Tonsillitis N/A
Recruiting NCT04646525 - The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Recruiting NCT03137823 - Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface N/A
Completed NCT02571075 - Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea N/A
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4
Recruiting NCT04164511 - Does Ice Cream Help With Post-tonsillectomy Pain
Completed NCT04653376 - Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases