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

NCT ID: NCT04704622

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-02-15

Brief Summary

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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

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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.

Conditions

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Cannula Site Pain

Keywords

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dexmedetomidine ketamine midazolam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine group

dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative

ketamine

ketamine intranasal injection,2 mg/kg, once, 30 min preoperative

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

ketamine intranasal injection,2 mg/kg, once, 30 min preoperative

midazolam

midazolam intranasal injection,0.2 mg/kg, once, 30 min preoperative

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative

Interventions

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Ketamine

ketamine intranasal injection,2 mg/kg, once, 30 min preoperative

Intervention Type DRUG

Midazolam

midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative

Intervention Type DRUG

Dexmedetomidine

dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative

Intervention Type DRUG

Other Intervention Names

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ket mid dex

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Gamal Abusinna

lecturer of anesthesia and intensive care, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasha G Abusinna, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University Hospital

Cairo, EL Abassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Rasha Abusinna

Identifier Type: -

Identifier Source: org_study_id