Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores
Information source: Makerere University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: dexamethasone (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Makerere University
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.
Clinical Details
Official title: Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores: A Double Blinded Randomised Controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: 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.
Secondary outcome: : Adverse effects of the dexamethasone
Detailed description:
RESEARCH QUESTION TO BE ADDRESSED BY THIS RESEARCH Does intraoperative dexamethasone 12mg
reduce 24 hour post-operative pain scores of adult patients undergoing elective
laparotomies, thyroidectomies and mastectomies in Mulago hospital RATIONALE FOR THE RESEARCH
The treatment of acute post-operative pain is an important health care issue. Inspite of
that, its under treatment has been widely recognised over the past two decades. A variety of
cultural, attitudinal, religious, educational, political and logistical reasons can be
attributed to this and there are a variety of physiological and psychological side effects
of this pain.
Dexamethasone is a cheap and readily available drug in Uganda and it has been shown to have
analgesic properties.
However, only a few studies have been done to assess these analgesic effects and they have
majorly been in tonsillectomies and cardiac surgery. A few such studies have been done on
general surgery patients. Most of these studies have been done outside Africa and yet they
have demonstrated positive results with regards to optimising analgesia and reducing the
post-operative opioid requirements of patients.
This study is yet to be done in Uganda and all the available literature may not necessarily
apply to this setting.
GENERAL OBJECTIVE To study the effect of intraoperative dexamethasone 12 mg versus placebo
on 24 hour post-operative pain scores of adult patients undergoing elective laparotomies,
mastectomies and thyroidectomies in Mulago hospital.
SPECIFIC OBJECTIVES PRIMARY OBJECTIVE To compare the 24 hour post-operative pain scores
after intraoperative dexamethasone 12mg versus placebo in adult patients undergoing elective
laparotomies, mastectomies and thyroidectomies in Mulago hospital.
SECONDARY OBJECTIVE To compare the adverse events associated with intraoperative
dexamethasone 12mg versus placebo in adult patients undergoing elective laparotomies,
mastectomies and thyroidectomies in Mulago hospital.
METHODS Study design: a phase 2 prospective randomized, double blinded, placebo-controlled
trial Study site: Mulago National Refferal Hospital. Study population: Adult patients
undergoing elective laparotomies, mastectomies and thyroidectomies in Mulago hospital, who
meet the inclusion criteria and consent to participate in the study.
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.
Randomization: block randomization Blinding: double blinded Sample size: 170 patients
Study procedure:
1. Premedication consisted of midazolam and fentanyl .
2. Anaesthesia was induced using intravenous propofol or thiopental.
3. Maintenance of anaesthesia was done using inhalation anaesthesia i. e isoflurane or
sevoflurane.
4. The intervention (dexamethasone or placebo) was given 15 minutes following induction of
anaesthesia.
5. 30 minutes prior to the end of the procedure, an opioid (morphine) was given
intravenously for post operative pain management in the immediate post operative
period.
6. Post-operative pain was managed using tramadol or pethidine.
7. Breakthrough pain was managed using intravenous diclofenac as the drug of choice or
intravenous paracetamol for those who cannot tolerate opioids.
8. The patients' pain scores were assessed in the post anaesthesia care unit before being
discharged to their parent wards.
9. A research assistant was allocated to these patients while on the ward, to ensure
timely administration of analgesia as well as the management of breakthrough pain.
10. The pain scores were assessed at 12 and 24 hours, by research assistants who will have
been trained on how to administer the numerical rating scale. Their pain scores were
assessed using this tool and the adverse reactions assessed.
RISKS OR BENEFITS TO SUBJECTS This is a minimal risk study. There have been no demonstrated
risks of the drug at these doses. All patients who might react to the drug will be
eliminated from the study.
COMPENSATION/REIMBURSEMENT No patient was expected to pay for this study. Patients were not
reimbursed for participating in the study.
CONSENT informed consent was sought from the patients prior to surgery. CONFIDENTIALITY
ASSURANCES Patient names and in patient numbers were not collected in order to ensure utmost
confidentiality. The other data that was collected was safely stored on multiple soft
copies and storage devices in separate places, as were the questionnaires.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Mulago Hospital National Refferal, surgical wards, Kampala +256, Uganda
Additional Information
Starting date: July 2014
Last updated: April 22, 2015
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