Different Premedication in Pediatric Patients

NCT04266340 | Completed

• 1 other identifier: 20180341
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group. Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium \[PAED\] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.

Conditions

Agitation

Outcome Measures

Primary Outcomes (6)

• Sedation

  1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated

  10 minutes after premedication

• Sedation

  1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated

  20 minutes after premedication

• Sedation

  1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated

  30 minutes after premedication

• Emotional state

  1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting

  0 minutes after they were separated from their parents

• Emotional state

  1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting

  0 minutes after intravenous cannulation

• Emotional state

  1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting

  0 minutes after facemask application

Study Arms (4)

placebo

PLACEBO COMPARATOR

no premedication

Drug: Saline

oralmidazolam

EXPERIMENTAL

0.5 mg/kg oral midazolam group

Drug: midazolam

intravenous midazolam

EXPERIMENTAL

0.05 mg/kg intravenous injection midazolam group

Drug: midazolam

dexmedetomidine

EXPERIMENTAL

2.5µg/kg intranasal dexmedetomidine group

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

2.5µg/kg intranasal dexmedetomidine group

dexmedetomidine

midazolam DRUG

0.5mg/kg oral midazolam

oralmidazolam

Saline DRUG

no premedication

placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• Qiao H, Chen J, Lv P, Ye Z, Lu Y, Li W, Jia J. Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial. Transl Pediatr. 2022 Nov;11(11):1751-1758. doi: 10.21037/tp-22-161.

  PMID: 36506775 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Dexmedetomidine; Midazolam; Sodium Chloride

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 12, 2020
• Study Start: December 13, 2020
• Primary Completion: November 15, 2021
• Study Completion: December 1, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)