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

Ketamine

Brief Summary

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

Intervention / Treatment

  • ketamine-ketorolac (DRUG)
    The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
  • fentanyl- ketorolac (DRUG)
    The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly

Condition or Disease

  • Hematological Malignancy (Leukemia- Lymphoma)

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 7 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Aug 26, 2018 ACTUAL
    Primary Completion: Oct 01, 2018 ACTUAL
    Completion Date: Oct 15, 2018 ACTUAL
    Study First Posted: Aug 28, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 06, 2020

    Sponsors / Collaborators

    Lead Sponsor: Mansoura University
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • The patient will receive ketamine in conjunction with intramuscular ketorolac

    • The patient will receive fentanyl in conjunction with intramuscular ketorolac

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 7
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    • Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale)The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.

    Secondary Outcomes

    • Heart rate (beat/minute) using ECG monitoring

    • systolic blood pressure (mmHg) using sphygmomanometer cuff

    • The time to the first demand for rescue analgesic (minutes or hours)

    • total number of children who required postoperative pain medication for 24 hours after surgery

    • -emergence behavior will be measured using Aono's four point scale : (1) Asleep; (2) Awake but calm; (3) Agitated but consolable; and (4) Severely agitated and difficult to console and the highest-recorded value was recorded during the Post anesthesia care unit stay. Lowest score is 1 and highest score is 4 The higher score indicates more emergence agitation. For purposes of analysis, grades 1 and 2 in the scale of behavior were considered no agitation and grades 3 and 4 were considered the presence of agitation.

    • Number of attacks of nausea and/or vomiting

    • signs of respiratory difficulty: 1. Breathing rate. An increase in the number of breaths per minute (\>35 breath/minute) 2. Increased heart rate. 3. Color changes. A bluish color seen around the mouth, on the inside of the lips, or on the fingernails 4. Grunting. A grunting sound can be heard each time the person exhales. 5. Nose flaring. The openings of the nose spreading open while breathing 6. Retractions. The chest appears to sink in just below the neck and/or under the breastbone with each breath- 7. Sweating. There may be increased sweat on the head, but the skin does not feel warm to

    More Details

    NCT Number: NCT03649334
    Other IDs: R/18.06.213
    Study URL: https://clinicaltrials.gov/study/NCT03649334
    Last updated: Sep 29, 2023