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NCT Number: NCT07268924

The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.

This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation .

Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery.

Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA .

Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA.

So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective tonsillectomy operation
  • pediaterics between ( 4 : 7 ) years old
  • ASA I OR II

Exclusion criteria

  • emergency cases as bleeding tonsills
  • ASA III OR IV

Treatment and study plan

Propofol

Drug

In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus

Lidocaine %2 ampoule

Drug

In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Primary outcomes

  1. To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.

    Time frame: Within 30 minutes after extubation

    Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

  2. To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale

    Time frame: Within 30 minutes after extubation.

    Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).

Secondary outcomes

  1. emergence time from anesthesia

    Time frame: Within 30 minutes after extubation.

  2. peaked PAED scores

    Time frame: Within 30 minutes after extubation.

    Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

  3. extubation time

    Time frame: Within 30 minutes after extubation.

  4. post-operative pain using FLACC score

    Time frame: Within 30 minutes after extubation.

    The FLACC scale is used to assess postoperative pain in children. It consists of 5 categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, giving a total score range of 0-10.

  5. Hemodynamic effects as hypotention and bradycardia

    Time frame: Within 30 minutes after extubation.

  6. Post operative nausea and vomitting

    Time frame: Within 30 minutes after extubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Hesham Bahaaeldin Mohamed, Resident doctor

CONTACT

[email protected]

+201069896083

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

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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