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Doing sedation in paediatric

Effect of Nitrous Oxide for propofol requirement in painful procedures in pediatric oncology unit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015090513364N2
Enrollment
88
Registered
2016-12-05
Start date
2014-11-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: AML. Condition 2: ALL. Acute myeloblastic leukaemia [AML] Acute lymphoblastic leukaemia [ALL]

Interventions

Intervention 1: In the control group, combination of midazolam 0/03 mg / kg and fentanyl 1 µg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously. Intervention 2: In the stu
Treatment - Drugs
In the control group, combination of midazolam 0/03 mg / kg and fentanyl 1 µg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously.
In the study group, combination of midazolam 0/03 mg / kg and fentanyl 1 µg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously and the patients are ventilated with entonox,

Sponsors

Vice Chancellor for Research and Technology,Shahid Beheshti University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 16 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:patients undergoing bone marrow biopsy (the first turn) exclusion criteria:History of asthma;Catching common cold;detection of any complications during the procedure ( apnea;%90 = SPo2;Bradycardia > %30 of baseline);Doing any previous procedure with sedation;Parent discontent;Not fasting;History of hypersensitivity to any of the drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation scale. Timepoint: 1 minute. Method of measurement: Ramsay sedation scale.

Secondary

MeasureTime frame
Recovery time. Timepoint: After the procedure. Method of measurement: minute.;SpO2. Timepoint: Before administration of drugs - immediately before the procedure - at the beginning of the procedure - at the end of the procedure. Method of measurement: Pulse Oximeter.;Heart rate. Timepoint: Before administration of drugs - immediately before the procedure - at the beginning of the procedure - at the end of the procedure. Method of measurement: Pulse Oximeter.;Physician satisfaction. Timepoint: During the procedure. Method of measurement: VAS (10-0).;Nurse satisfaction. Timepoint: During the procedure. Method of measurement: VAS (10-0).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Taheri

Shahid Beheshti University of Medical Sciences

taheri.1352@yahoo.com+98 21 23871

Outcome results

None listed

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