Oral Dexmedetomidine for Parental Separation in Pediatrics Undergoing Adenotonsillectomy

NCT03551067 | Completed Phase 4

• 1 other identifier: 2886
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of oral dexmedetomidine as sedative versus a combination of oral midazolam plus oral ketamine were compared regarding to satisfactory separation from parents, satisfactory mask induction and postoperative rescue analgesia in Pediatrics undergone Adenotosillectomy

Conditions

Adenotonsillectomy

Keywords

Dexmedetomidine; Adenotonsillectomy; Parental Separation; Face Mask Acceptance

Outcome Measures

Primary Outcomes (1)

• Face mask acceptance

  Five-point scale was used to assess mask acceptance: 1. = Combative, crying. 2. = Moderate fear of the mask, not easily calmed. 3. = Cooperative with reassurance. 4. = Calm, cooperative. 5. = Asleep, steal induction. (Scores 1 and 2): Unacceptable conditions. (Scores 3, 4 and 5): Acceptable conditions.

  The anesthetist asked the child to blow the balloon for induction and assessment was recorded just after anesthesia induction

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Patients received Dexmedetomidine (4 µg/kg) mixed with apple juice to fill the syringe up to 10 ml given orally once.

Drug: Dexmedetomidine

Midazolam/Ketamine

ACTIVE COMPARATOR

Patients received Midazolam (0.5 mg/kg) and Ketamine (1 mg/kg) mixed with apple juice to fill the syringe up to 10 ml given orally once.

Combination Product: Midazolam/Ketamine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine mixed with juice was given to the child orally preoperatively.

Also known as: Alpha 2 agonist

Dexmedetomidine

Midazolam/Ketamine COMBINATION_PRODUCT

Midazolam/Ketamine was mixed with juice and given to the child orally preoperatively

Also known as: Dormicum/Katalar

Midazolam/Ketamine

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with ASA I (American Society of Anesthesiologists physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations)
• Children scheduled for adenotonsillectomy

You may not qualify if:

• Children with central nervous system disorders \& neurological problems.
• Children with inborn errors of metabolism.
• Obese children (BMI \>30 kg/m2).
• Children with known allergy to dexmedetomidine, midazolam or ketamine.
• Children who vomit.
• Children with recent or chronic administration of sedative drugs, antipsychotics or tranquilizers.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Anesthesia Department, Faculty of Medicine, Suez Canal University

Ismailia, 41511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Adrenergic alpha-2 Receptor Agonists; Midazolam; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mohamed Elsadany, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Ghada Kamhawy, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Reda mohmd, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Mohamed Abdelgawad, MD

  Suez Canal University

  STUDY DIRECTOR

• Ahmed Elewa, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Anesthesiology

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 11, 2018
• Study Start: August 1, 2016
• Primary Completion: December 15, 2017
• Study Completion: January 5, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)