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Completed

NCT Number: NCT03649334

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

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

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Key information

Conditions

Hematological Malignancy (Leukemia- Lymphoma) Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postoperative pain

    Time frame: for 60 minutes later admission to the post-anaesthesia care unit

    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

  1. Heart rate

    Time frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes

    Heart rate (beat/minute) using ECG monitoring

  2. systolic blood pressure

    Time frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes

    systolic blood pressure (mmHg) using sphygmomanometer cuff

  3. The time to the first demand for rescue analgesic

    Time frame: during first 24 hours postoperative

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

  4. total number of children who required postoperative pain medication

    Time frame: for 24 hours after surgery

  5. emergence behavior

    Time frame: every 5 minutes during first 30 minutes of recovery

    -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.

  6. nausea, vomiting

    Time frame: during first 24 hours postoperative

    Number of attacks of nausea and/or vomiting

  7. respiratory difficulty

    Time frame: during first 24 hours postoperative

    signs of respiratory difficulty:

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2018
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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