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NCT Number: NCT05609955

Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

This study aims to compare two groups of post-orthopedic patients who received a standard regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and adjuvant magnesium sulfate 30mg/kgBW 1 hour preoperatively. If it is proven useful, it is hoped that pain will be more controlled, reduce pain complications, reduce treatment costs, and reduce the duration of hospital stays.

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Key information

Conditions

Anesthesia Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

The study design used was a randomized controlled trial (RCT) with double blinds. Double blind because neither the patient, the lead investigator, nor the investigator on record knew the drug or placebo that was administered. Research subjects were selected consecutively in patients who will undergo lower extremity surgery at the Cipto Mangunkusumo National Central General Hospital. Forty-eight research subjects will be divided into two groups, namely the group given Intravenous Magnesium Sulfate 30 mg/kgBW and the group given a placebo. Research subjects were randomized by type of surgery using randomization software by research assistants. The results of randomization were not known to the patient, the principal investigator, or the researcher taking notes.

This study aims to determine the effect of adding 30 mg/kg body weight of intravenous MgSO4 to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing lower extremity orthopedic surgery under general anaesthesia.
  • Patients aged 18-60 years.
  • Physical status ASA 1-3
  • Willing to participate in research.

Exclusion criteria

  • Patients who are hemodynamically unstable.
  • Patients with decreased renal function
  • Patients with skeletal muscle disorders.
  • Patients with Ketorolac allergy
  • Patients with morphine allergy

Treatment and study plan

MgSO4

Drug

The treatment group who received intravenous magnesium sulfate therapy with 20% magnesium sulfate regimen, 30mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously

Primary outcomes

  1. Visual analogue scale

    Time frame: 24 hour

    The scale for measuring pain felt by the patient is in the form of a horizontal straight line 100 mm long. In the VAS examination, the patient is asked to point to a point along the line that reflects the degree of pain felt. There is a millimeter ruler for calculating the VAS score. A score of 0 = no pain and a score of 10 = unbearable severe pain.

Secondary outcomes

  1. Morphine consumption

    Time frame: 24 hour

    The number of milligrams (mg) of intravenous morphine in the first 24 hours postoperatively using a PCA device.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac : Study to Assess Pain And Opioid Consumption in Post Lower Extremity Orthopedic Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2022
Registry last updated
Nov 8, 2022

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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