The effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia in sayedoshohada Medical Center in Isfahan in 2016.

Comparative evaluation of the effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017080935601N1

Enrollment

Registered

2017-11-19

Start date

2016-09-19

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

Acute lymphoblastic leukaemia [ALL]. This code should only be used for T-cell and B-cell precursor leukeamia

Interventions

Intervention 1: Group 1 Propofol Ketamine (PK) Syringes No. 1, 2 and 3 containing propofol at a concentration of 1 mg per cc, ketamine with a concentration of 0.3 mg per cc, and normal saline (as plac

Treatment - Drugs

Group 1 Propofol Ketamine (PK) Syringes No. 1, 2 and 3 containing propofol at a concentration of 1 mg per cc, ketamine with a concentration of 0.3 mg per cc, and normal saline (as placebo) 1 cc per k

Group II propofol remifentanil (PR) syringe number 4, containing propofol at a concentration of 1.5 mg / kg, syringe number 5 containing remifentanil at a concentration of 1mcg / kg and syringe n

Eligibility

Sex/Gender

All

Age

6 Months to 14 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were included, Children aged between Six months to fourteen years old with Hematologic Malignancies (such as acute lymphocytic leukemia) were candidates for painful intervention Lumbar Puncture; Bone marrow aspiration/Biopsy. Non-entry criteria include patients with head trauma; High intraocular pressure (IOP); or High intracranial pressure (ICP); cardiovascular or repertory or liver diseases; epilepsy or history of seizure; Neurological disorder ;tumor or metastasis of the brain; usage of analgesic or sedative drugs in before intervention; chronic pain syndrome; and not having to participate in the study; history of allergy or allergic reaction to Our study drugs Excluded criteria include any complications during intervention that causes the anesthetic program to change

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation Level. Timepoint: During Procedure. Method of measurement: University of Michigan Sedation Scale (UMSS).;Analgesia. Timepoint: During Procidure. Method of measurement: Universal Pain Assessment Tool (UPAT).	—

Secondary

Measure	Time frame
Hemodynamic changes ( Heart rate , Systolic and Diastolic blood pressure, Mean atria pressure). Timepoint: Before And Every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Cardiac monitoring and automatic blood pressure monitoring.;Arterial oxygen saturation. Timepoint: Before and every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Pulse oximeter.	—

Measure

Time frame

Hemodynamic changes ( Heart rate , Systolic and Diastolic blood pressure, Mean atria pressure). Timepoint: Before And Every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Cardiac monitoring and automatic blood pressure monitoring.;Arterial oxygen saturation. Timepoint: Before and every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Pulse oximeter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Shetabi

Isfahan University of Medical Sciences

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

Outcome results

None listed

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