Skip to main content
OpenTrials
Completed

NCT Number: NCT02753725

Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)

This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anaesthesiologists classes (ASA) 1 and 2 children.
  • ASA 1 - Normal healthy child scheduled for adeno-tonsilectomy.
  • ASA 2 - Child with mild systemic disease without functional limitations.
  • Children aged 1 to 12 years.
  • Children undergoing elective adeno-tonsilectomy.
  • Those children whose parents/guardians have given a written informed consent.

Exclusion criteria

  • Children with genetic syndromes.
  • Children with psychological/neurological behavioural disorders.
  • Children with allergies to Fentanyl.
  • Children with psychiatric disorders/ use of psychiatric medications.
  • Use of sedative medications one hour prior to surgery.
  • Children with developmental delay.
  • Children coming in as day case.
  • Children with airway problems not related to the surgery-sleep apnoea.
  • Children less than 1 year and those above 13 years.

Treatment and study plan

Fentanyl

Drug

The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.

Other names: treatment

normal saline

Drug

the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed

Other names: placebo

Primary outcomes

  1. The number of patients who develop emergence delirium in both arms

    Time frame: 30 minutes

    the number of patients who develop emergence delirium within 30 minutes after general anaesthesia will be assessed using Watcha scale indicated in the study questionnaire,

  2. the local incidence of emergence delirium.

    Time frame: 30 minutes

    local incidence of emergence delirium will be determined by the percentage of those who develop emergence delirium in the placebo group within 30 minutes after general anesthesia as assessed by Watcha scale.

Secondary outcomes

  1. the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.

    Time frame: 30 minutes

    the percentage of patients developing emergence delirium in both groups will be compared to determine if fentanyl prevents emergence delirium.

  2. duration of emergence time from general anaesthesia in minutes

    Time frame: 30 minutes

    the time taken to emerge from both arms will be compared to determine if fentanyl delays emergence time from general anaesthesia.

Sponsors and collaborators

Lead sponsor

University of Nairobi

Other

Registry information

Official study title

Effect of Fentanyl Given Approximately Ten Minutes to the End of Surgery on Emergence Delirium in Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital: A Randomized Placebo Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Jul 18, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.