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

NCT03649334 | Completed Phase 4 DMC

• 1 other identifier: R/18.06.213
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematological Malignancy (Leukemia- Lymphoma)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Heart rate

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

• systolic blood pressure

  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

  during first 24 hours postoperative

• total number of children who required postoperative pain medication

  for 24 hours after surgery

• emergence behavior

  every 5 minutes during first 30 minutes of recovery

Study Arms (2)

ketamine-ketorolac

OTHER

The patient will receive ketamine in conjunction with intramuscular ketorolac

Drug: ketamine-ketorolac

fentanyl- ketorolac

OTHER

The patient will receive fentanyl in conjunction with intramuscular ketorolac

Drug: fentanyl- ketorolac

Interventions

ketamine-ketorolac DRUG

The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.

ketamine-ketorolac

fentanyl- ketorolac DRUG

The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly

fentanyl- ketorolac

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status II

You may not qualify if:

• Any known allergy to the studied drugs.
• congenital heart disease
• Any cardiac problems.
• Use of psychotropic medication
• mental retardation
• any organ dysfunction

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Enas A Abd el Motlb, MD

  Assisitant Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 28, 2018
• Study Start: August 26, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 15, 2018
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

EG (1)