The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ngamjit Pattaravit, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01440114
First received: September 22, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.


Condition Intervention
Agitation
Drug: fentanyl
Drug: NSS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • the incidence of emergence agitation [ Time Frame: pt was observed since emerging from anesthesia up to 60 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of emergence agitation [ Time Frame: pt was observed since emerging from anesthesia up to 60 minutes ] [ Designated as safety issue: Yes ]
  • adverse effect from intravenous fentanyl prior the end of surgery [ Time Frame: pt was observed since emerging from anesthesia upto 60 minutes ] [ Designated as safety issue: Yes ]
  • post operative pain [ Time Frame: pt was observed since emerging from anesthesia up to 60 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 144
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fentanyl group
First arm: intervention group. Patient in this group received fentanyl 1 mcg/kg (concentration 10mcg/ml) intravenous route 15 minutes before the end of surgery.
Drug: fentanyl
In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
Placebo Comparator: controlled group
patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
Drug: NSS
Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

Detailed Description:

Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 2-9 years
  • IPD patient
  • Receiving Chloral hydrate 50mg/kg (BW<20 kgs)or midazolam 0.1 mg /kg (BW>20 kgs)Per oral for premedication
  • Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.

Exclusion Criteria:

  • ASA physical status IV-V
  • History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440114

Locations
Thailand
Faculty of Medicine, Prince of Songkla University
Hat-Yai, Sonkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
  More Information

No publications provided

Responsible Party: Ngamjit Pattaravit, Doctor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01440114     History of Changes
Other Study ID Numbers: PSUEA1
Study First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Prince of Songkla University:
emergence agitation
pediatric patient
fentanyl
incidence of emergence agitation
severity of emergence agitation
adverse outcome from intervention

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 28, 2014