Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores
DOPP
1 other identifier
interventional
173
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Jul 2014
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedApril 23, 2015
April 1, 2015
7 months
February 20, 2015
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
pain scores assessed using the numerical rating scale, at three points i.e the PACU, 12 and 24 hours post operatively
1 year
Secondary Outcomes (1)
: Adverse effects of the dexamethasone
1 year
Study Arms (2)
group1
ACTIVE COMPARATOR12 mg( 3 mls) of dexamethasone given 15 mins after induction of anesthesia
group2
PLACEBO COMPARATOR3 mls of placebo( normal saline) given 15 mins after induction of anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with Cushing's disease or Cushing's syndrome
- Patients with diabetes mellitus
- Systemic infection
- Previous history of TB infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mulago Hospital National Refferal, surgical wards
Kampala, +256, Uganda
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 26, 2015
Study Start
July 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 23, 2015
Record last verified: 2015-04