Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Hematological Malignancy (Leukemia- Lymphoma)

Treatments: Drug: ketamine-ketorolac; Drug: fentanyl- ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03649334

R/18.06.213

Details and patient eligibility

About

investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy

Full description

regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)

• Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Enrollment: 80 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status II

Exclusion criteria

• Any known allergy to the studied drugs.
• congenital heart disease
• Any cardiac problems.
• Use of psychotropic medication
• mental retardation
• any organ dysfunction

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

ketamine-ketorolac

Other group

Description:

The patient will receive ketamine in conjunction with intramuscular ketorolac

Treatment:

Drug: ketamine-ketorolac

fentanyl- ketorolac

Other group

Description:

The patient will receive fentanyl in conjunction with intramuscular ketorolac

Treatment:

Drug: fentanyl- ketorolac