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Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores (DOPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372812
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
College of Health Sciences, Makerere University

Brief Summary:
A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this dose were also assessed for.

Condition or disease Intervention/treatment Phase
Pain Drug: dexamethasone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores: A Double Blinded Randomised Controlled Clinical Trial
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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Arm Intervention/treatment
Active Comparator: group1
12 mg( 3 mls) of dexamethasone given 15 mins after induction of anesthesia
Drug: dexamethasone
12 mg of dexamethasone

Placebo Comparator: group2
3 mls of placebo( normal saline) given 15 mins after induction of anesthesia
Drug: Placebo



Primary Outcome Measures :
  1. Post- operative pain scores of the patients using the numerical rating scale, that grades pain from 1-10. The patients will have this scale explained to them. This will be done 24 hours following administration of intraoperative dexamethasone. [ Time Frame: 1 year ]
    pain scores assessed using the numerical rating scale, at three points i.e the PACU, 12 and 24 hours post operatively


Secondary Outcome Measures :
  1. : Adverse effects of the dexamethasone [ Time Frame: 1 year ]
    patients were asked if they had got any drug reactions, their temperatures and glucose levels were assessed.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Patients scheduled for mastectomies, laparotomies and thyroidectomies that have given informed consent to participate.

    • ASA I & II, patients that have none or have mild to moderate systemic illness.
    • Adult patients, above 18 years old.

Exclusion Criteria:

  • • Patients with Cushing's disease or Cushing's syndrome

    • Patients with diabetes mellitus
    • Systemic infection
    • Previous history of TB infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372812


Locations
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Uganda
Mulago Hospital National Refferal, surgical wards
Kampala, Uganda, +256
Sponsors and Collaborators
Makerere University
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Responsible Party: College of Health Sciences, Medical doctor, Makerere University
ClinicalTrials.gov Identifier: NCT02372812    
Other Study ID Numbers: 206000541
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015
Keywords provided by College of Health Sciences, Makerere University:
effect of dexamethasone
general surgery
post operative
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents