NCT03649334

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

Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hematological Malignancy (Leukemia- Lymphoma)

Interventions

Type	Name	Description
DRUG	ketamine-ketorolac	The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
DRUG	fentanyl- ketorolac	The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly

Timeline

• Start date: 2018-08-26
• Primary completion: 2018-10-01
• Completion: 2018-10-15
• First posted: 2018-08-28
• Last updated: 2020-09-09

Locations

1 site across 1 country: Egypt