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

NCT04704622 | Completed Phase 2

• 1 other identifier: Rasha Abusinna
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannula Site Pain

Keywords

dexmedetomidine; ketamine; midazolam

Outcome Measures

Primary Outcomes (1)

• the change of Modified Observer Assessment of Alertness and Sedation scale(MOAA/S) at different time intervals

  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.

  measuring the Modified Observer Assessment of Alertness and Sedation scale every 10 minutes preoperative till induction of anesthesia up to 30 minutes

Secondary Outcomes (4)

• the change in measuring pulse rate/ minutes at different time intervals

  the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours

• the change in Mean Arterial Pressure at different time intervals

  the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours

• the change in oxygen saturation at different time intervals

  the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours

• the ease of venipuncture score

  done by the anesthetist immediately after the cannula insertion

Study Arms (3)

dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Ketamine DRUG

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

Also known as: ket

ketamine

Midazolam DRUG

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

Also known as: mid

midazolam

Dexmedetomidine DRUG

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

Also known as: dex

dexmedetomidine group

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, EL Abassia, 11591, Egypt

Location

MeSH Terms

Interventions

Ketamine; TP63 protein, human; Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Rasha G Abusinna, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care, Principal Investigator

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 11, 2021
• Study Start: January 1, 2021
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)