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

NCT04704622 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-05-28

No results posted yet for this study

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

Interventions

DRUG

Ketamine

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

DRUG

Midazolam

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

DRUG

Dexmedetomidine

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Rasha G Abusinna, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-02-15
Completion
2021-02-15

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704622 on ClinicalTrials.gov