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

Cannula Site Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704622
• Other study ID #: Rasha Abusinna
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2021
• Est. completion date: February 15, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannula Site Pain

Intervention

Drug:
• Ketamine
ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
• Midazolam
midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative
• Dexmedetomidine
dexmedetomidine intranasal injection,1 µg/kg, once, 30 min preoperative

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo	EL Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the change in measuring pulse rate/ minutes at different time intervals	measuring pulse rate/ minutes every 10 minutes at baseline till the end of surgery	the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
Secondary	the change in Mean Arterial Pressure at different time intervals	measuring Mean Arterial Pressure every 10 minutes at baseline till the end of surgery	the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
Secondary	the change in oxygen saturation at different time intervals	measuring oxygen saturation every 10 minutes at baseline till the end of surgery	the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
Secondary	the ease of venipuncture score	poor, fair, good, excellent	done by the anesthetist immediately after the cannula insertion