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

Comparison of Analgesic and Sedative Effects of Midazolam-Ketamine and Propofol-Sufentanil Combinations during painful procedures in Children with Hematologic Malignancy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170809035601N8
Enrollment
124
Registered
2018-09-29
Start date
2017-06-22
Completion date
Unknown
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukaemia [ALL]. Acute lymphoblastic leukemia [ALL]

Interventions

Intervention 1: Two syringes containing the drug dosage required for each 10 kg body weight. Syringes will be prepared as propofol (7.5mg), Sufentanil 5 µg for PS group. Intervention 2: Control group

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Shetabi

Esfahan University of Medical Sciences

hamidshetabi@med.mui.ac.ir+98 31 3668 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026