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

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

Study Overview

• Status: Completed
• Conditions: Hematological Malignancy (Leukemia- Lymphoma)
• Intervention / Treatment: Drug: ketamine-ketorolac; Drug: fentanyl- ketorolac

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ketamine-ketorolac; The patient will receive ketamine in conjunction with intramuscular ketorolac	Drug: ketamine-ketorolac; The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
Other: fentanyl- ketorolac; The patient will receive fentanyl in conjunction with intramuscular ketorolac	Drug: fentanyl- ketorolac; The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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.	for 60 minutes later admission to the post-anaesthesia care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate (beat/minute) using ECG monitoring	at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
systolic blood pressure	systolic blood pressure (mmHg) using sphygmomanometer cuff	at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
The time to the first demand for rescue analgesic	The time to the first demand for rescue analgesic (minutes or hours)	during first 24 hours postoperative
total number of children who required postoperative pain medication		for 24 hours after surgery
emergence behavior	-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.	every 5 minutes during first 30 minutes of recovery
nausea, vomiting	Number of attacks of nausea and/or vomiting	during first 24 hours postoperative
respiratory difficulty	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	during first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Enas A Abd el Motlb, MD, Assisitant Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Fentanyl; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: R/18.06.213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No