Comparison of Analgesic and Sedative Effects of Midazolam-Ketamine and Propofol-Sufentanil

Phase 2

• Conditions: Acute lymphoblastic leukaemia [ALL].; Acute lymphoblastic leukemia [ALL]

• Registration Number: IRCT20170809035601N8
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Children 2 to 14 years old with Hematologic Malignancy
Candidate for painful diagnostic procedures

Exclusion Criteria

History of hypersensitivity or allergic reaction to any medication regimen
Use of any analgesic and anesthetic drug
Cardiovascular disease, respiratory disease, liver disease, epilepsy or a history of seizures, neurological disorders, brain tumor or metastasis.
The presence of chronic pain syndromes
Head injuries

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation level. Timepoint: During Procedure. Method of measurement: University of Michigan Sedation Scale (UMSS).;Analgesia. Timepoint: during procedure. Method of measurement: Universal Pain Assessment Tool(UPAT).

Secondary Outcome Measures

Name	Time	Method
Hemodynamic changes ( Heart rate , Systolic and Diastolic blood pressure, Mean atria pressure). Timepoint: Before and during the procedure and recovery time. Method of measurement: Cardiac monitoring and automatic blood pressure monitoring.;Arterial oxygen saturation. Timepoint: Before and during the procedure and recovery time. Method of measurement: Pulse oximeter.