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Completed

NCT Number: NCT01440114

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

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Confusion Delirium Dyskinesias Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.

NSS

Drug

Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

Primary outcomes

  1. the incidence of emergence agitation

    Time frame: pt was observed since emerging from anesthesia up to 60 minutes

Secondary outcomes

  1. severity of emergence agitation

    Time frame: pt was observed since emerging from anesthesia up to 60 minutes

  2. adverse effect from intravenous fentanyl prior the end of surgery

    Time frame: pt was observed since emerging from anesthesia upto 60 minutes

  3. post operative pain

    Time frame: pt was observed since emerging from anesthesia up to 60 minutes

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2011
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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