Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy
Keywords
Abstract
Dates
| Last Verified: | 07/31/2019 |
| First Submitted: | 10/22/2017 |
| Estimated Enrollment Submitted: | 11/08/2017 |
| First Posted: | 11/16/2017 |
| Last Update Submitted: | 08/05/2019 |
| Last Update Posted: | 08/07/2019 |
| Actual Study Start Date: | 11/25/2017 |
| Estimated Primary Completion Date: | 08/26/2018 |
| Estimated Study Completion Date: | 08/26/2018 |
Condition or disease
Intervention/treatment
Drug: fentanyl at 10-15 min before end of surgery
Drug: fentanyl at end of surgery
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: fentanyl at 10-15 min before end of surgery | Drug: fentanyl at 10-15 min before end of surgery Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl) |
| Active Comparator: fentanyl at end of surgery | Drug: fentanyl at end of surgery Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl) |
Eligibility Criteria
| Ages Eligible for Study | 3 Years To 3 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Pediatric patients aged 3 to 7 years with ASA 1-II scheduled for tonsillectomy (or adenoidal tonsillectomy) Exclusion Criteria: - 1. History of developmental disorder, cognitive impairment, cerebral palsy - 2. History of seizures(not simple febrile convulsions) - 3. Upper respiratory infections - 4. Structural airway disease predicting difficult airway - 5. History of an adverse reaction, including allergic reactions to fentanyl |
Outcome
Primary Outcome Measures
1. Incidence of postoperative nausea and vomiting [In 10-minute increments from immediately(less than 3 min) after entering PACU to departure]
Secondary Outcome Measures
1. PAED scale score: *Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence. [In 10-minute increments from immediately(less than 3 min) after entering PACU to departure]
2. five-step EA scale: *five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence. [In 10-minute increments from immediately(less than 3 min) after entering PACU to departure]
3. FLACC score FLACC score (Face, Legs, Activity, Cry, Consolability scale): range 0-10. If the score is 4 or more, Pain control is considered necessary. [In 10-minute increments from immediately after entering PACU to departure]
4. anesthesia recovery time [up to 1 day after end of surgery]
5. Occurrence of side effect [In 10-minute increments from immediately(less than 3 min) after entering PACU to departure]
