Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement

Pain Measurement Clinical Trial

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Official title:

Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763059
• Other study ID #: 1434/254/287
• Status: Completed
• Phase: Phase 4
• First received: May 1, 2016
• Last updated: May 4, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Research Ethics Committee of King Abdulaziz University Faculty of Dentistry. Jeddah, Saudi Arabia:
• Study type: Interventional

Clinical Trial Summary

Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement.

Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery:

1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);

2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or

3. placebo.

Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed consent for the described procedure

• Surgical placement of a single endosteal implant

• Age of at least 18 years

Exclusion Criteria:

• The need for bone grafting or sinus lift for implant placement

• Pregnant and lactating women

• Metabolic disorders

• Immunocompromised status

• Hemophilia or bleeding disorders

• Drug or alcohol abuse

• Treatment with steroids in the previous 6 months

• History of radiation therapy in the head and neck

• Psychiatric disorders

• Inability to understand the procedure described in the questionnaire

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Drug:
• Ibuprofen 600 mg
This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
• Dexamethasone 4 mg
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
• Placebo
This group receives 1 hour before surgery placebo.
• Acetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visual analog scale (VAS) was used to measures levels of pain.	a visual analog scale (VAS) consisting of a 10-cm line with two extremes at either end; "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represented their level of perceived pain.	8 hours-time	Yes
Secondary	the 101-point numerical rate scale (NRS-101) was used to measures levels of pain.	the patients were asked to rate their pain intensity on a numeric scale ranging from 0 to 100.	8 hours-time	Yes
Secondary	The 4-point verbal rating scale (VRS-4) was used to measures levels of discomfort.	the patient specifies one of four options: no discomfort, some discomfort, considerable discomfort, or discomfort that could not be more severe.	8 hours-time	Yes