ClinicalTrials.gg
Status unknownNCT02848287Updated Jul 28, 2016

Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

An interventional study of normal saline and ropivacaine in Tonsillitis, sponsored by Ajou University School of Medicine. Status unknown. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2016-07-28.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tonsillitis

Browse trials for

03

In context

Tonsillitis

104 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's planned enrollment of 84 is below the median of 100 across 89 interventional studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • American Society of anesthesiologist physical status class I/II
  • tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • obstructive sleep apnea
  • developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Placebo comparator
    Normal Saline

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

    Drug: normal saline

  • Experimental
    Ropivacaine

    1\*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.

    Drug: ropivacaine

Interventions

  • Drugnormal saline

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

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

06

What researchers measure

Primary outcomes

  1. Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission

    PAED score is assessed

    Time frame: 1 min after postanesthesia care unit (PACU) admission

Secondary outcomes

  1. Face legs activity cry consolability (FLACC) score

    FLACC score is assessed.

    Time frame: 1 min after postanesthesia care unit (PACU) admission

  2. PAED score 10 min after PACU admission

    Time frame: 10 min after postanesthesia care unit (PACU) admission

  3. PAED score 20 min after PACU admission

    Time frame: 20 min after postanesthesia care unit (PACU) admission

  4. PAED score 30 min after PACU admission

    Time frame: 30 min after postanesthesia care unit (PACU) admission

  5. FLACC score 10 min after PACU admission

    Time frame: 10 min after postanesthesia care unit (PACU) admission

  6. FLACC score 20 min after PACU admission

    Time frame: 20 min after postanesthesia care unit (PACU) admission

  7. FLACC score 30 min after PACU admission

    Time frame: 30 min after postanesthesia care unit (PACU) admission

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02848287
Responsible party
Go Un Roh (Clinical assistant professor, primary investigator, Ajou University School of Medicine) — Principal investigator
First posted
Jul 28, 2016
Start date
Aug 2016
Primary completion
Jul 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
Jul 28, 2016

Study contacts

Go Un Roh, MD
Contact
gone7968@aumc.ac.kr
82-31-219-6435

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ropivacaine

Start the discussion