Clinical trial NCT03649334: Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
Official title: Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematological Malignancy (Leukemia- Lymphoma)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: for 60 minutes later admission to the post-anaesthesia care unit
Secondary outcomes:
measure: Heart rate
timeFrame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
measure: systolic blood pressure
timeFrame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
measure: The time to the first demand for rescue analgesic
timeFrame: during first 24 hours postoperative
measure: total number of children who required postoperative pain medication
timeFrame: for 24 hours after surgery
measure: emergence behavior
timeFrame: every 5 minutes during first 30 minutes of recovery
measure: nausea, vomiting
timeFrame: during first 24 hours postoperative
measure: respiratory difficulty
timeFrame: during first 24 hours postoperative
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Assisitant Professor
name: Enas A Abd el Motlb, MD
role: STUDY_CHAIR
References: