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Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient

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ClinicalTrials.gov Identifier: NCT04704622
Recruitment Status : Completed
First Posted : January 11, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Rasha Gamal Abusinna, Ain Shams University

Tracking Information
First Submitted Date  ICMJE January 4, 2021
First Posted Date  ICMJE January 11, 2021
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE January 1, 2021
Actual Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
the change of Modified Observer Assessment of Alertness and Sedation scale(MOAA/S) at different time intervals [ Time Frame: measuring the Modified Observer Assessment of Alertness and Sedation scale every 10 minutes preoperative till induction of anesthesia up to 30 minutes ]
scale measuring level of sedation from 1-6 points. 1 is referring to no sedation and 6 is the maximum sedation. reaching score of 4 is the sedation level needed to insert the cannula.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
  • the change in measuring pulse rate/ minutes at different time intervals [ Time Frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours ]
    measuring pulse rate/ minutes every 10 minutes at baseline till the end of surgery
  • the change in Mean Arterial Pressure at different time intervals [ Time Frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours ]
    measuring Mean Arterial Pressure every 10 minutes at baseline till the end of surgery
  • the change in oxygen saturation at different time intervals [ Time Frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours ]
    measuring oxygen saturation every 10 minutes at baseline till the end of surgery
  • the ease of venipuncture score [ Time Frame: done by the anesthetist immediately after the cannula insertion ]
    poor, fair, good, excellent
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient
Official Title  ICMJE Comparative Evaluation of Intranasal Midazolam, Dexmedetomidine, Ketamine for Their Sedative Effect and the Ability to Facilitate Venous Cannulation in Pediatric Patients: a Prospective Randomized Study.
Brief Summary Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures. Methods: the patients agreed to participate in the research were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded.
Detailed Description

Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. We assumed that intranasal midazolam, dexmedetomidine and ketamine would help anesthetics to carry out venous cannulation easily; in addition to their sedative premedication effect.

The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures.

Study design: 150 patients agreed to participate in the research after written informed consent. patients were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded. Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cannula Site Pain
Intervention  ICMJE
  • Drug: Ketamine
    ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
    Other Name: ket
  • Drug: Midazolam
    midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative
    Other Name: mid
  • Drug: Dexmedetomidine
    dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
    Other Name: dex
Study Arms  ICMJE
  • Active Comparator: dexmedetomidine group
    dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: ketamine
    ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
    Intervention: Drug: Ketamine
  • Active Comparator: midazolam
    midazolam intranasal injection,0.2 mg/kg, once, 30 min preoperative
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 15, 2021
Actual Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: all the following must be included

  • child aged between 2-9 years scheduled for minor elective surgical procedures (last 1-2 hours) at pediatric surgery department.
  • Patients were ASA I or II.
  • within normal range of weight.
  • refusing venous cannulation

Exclusion Criteria: any of the following

  • parents' refusal
  • with nasal deformity or pathology
  • any known case of allergy to the study drugs
  • obese patients
  • suspected difficult airway or venous cannulation.
  • maxillofacial malformations
  • gastroesophageal reflux
  • patients with renal, liver, endocrine or cardiac pathology
  • patients with increased intracranial or intraocular pressure
  • patients with sleep apnea
  • any patient with a preexisting cannula or accepting cannula insertion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04704622
Other Study ID Numbers  ICMJE Rasha Abusinna
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rasha Gamal Abusinna, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rasha G Abusinna, MD Ain Shams University hospitals
PRS Account Ain Shams University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP