Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 mg of dexamethasone
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: effect of dexamethasone; general surgery; post operative