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Injectable Diclofenac for the Prevention of Post-operative Dental Pain (DP4)

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ClinicalTrials.gov Identifier: NCT01706588
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : August 28, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Diclofenac sodium
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Hide Arm/Group Description Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Period Title: Overall Study
Started 15 15 15 14 16
Completed 15 15 15 14 16
Not Completed 0 0 0 0 0
Arm/Group Title Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL Total
Hide Arm/Group Description Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 14 16 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 14 participants 16 participants 75 participants
28  (7.3) 28  (9.4) 30  (9) 27  (4.5) 30  (9.5) 28.6  (7.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 14 participants 16 participants 75 participants
Female
9
  60.0%
6
  40.0%
12
  80.0%
8
  57.1%
12
  75.0%
47
  62.7%
Male
6
  40.0%
9
  60.0%
3
  20.0%
6
  42.9%
4
  25.0%
28
  37.3%
1.Primary Outcome
Title Area Under the Curve (AUC) of the Pain Scores.
Hide Description Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Time Frame Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Hide Arm/Group Description:
Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Overall Number of Participants Analyzed 15 15 15 14 16
Mean (Standard Deviation)
Unit of Measure: mm*minutes
6843  (6259) 8832  (6330) 9998  (8080) 7290  (6509) 15539  (9279)
2.Secondary Outcome
Title Postsurgical Extra-oral Swelling
Hide Description [Not Specified]
Time Frame measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Trismus
Hide Description [Not Specified]
Time Frame measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Peak Pain Intensity
Hide Description [Not Specified]
Time Frame measured from end of surgery up to 12 hours postsurgery
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to First Use of Rescue Medication.
Hide Description [Not Specified]
Time Frame measured from end of surgery up to 1 week postsurgery
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Amount of Rescue Medication
Hide Description [Not Specified]
Time Frame consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Rescue Medication Consumption
Hide Description [Not Specified]
Time Frame consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Patient and Investigator Global Evaluation of the Effectiveness of Treatment
Hide Description [Not Specified]
Time Frame at 6 hour postsurgery and on Day 3
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Time to Onset of Pain
Hide Description [Not Specified]
Time Frame measured from end of surgery up to 12 hours postsurgery
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Wound Healing
Hide Description [Not Specified]
Time Frame at 6 hour postsurgery, and on day 3 and 1 week postsurgery
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Recurrent Bleeding
Hide Description [Not Specified]
Time Frame every hour up to 6 hour postsurgery
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Vital Signs
Hide Description [Not Specified]
Time Frame presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description [Not Specified]
Time Frame from signature of the informed consent to 1 week postsurgery
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Hide Arm/Group Description Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
All-Cause Mortality
Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/14 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac Sodium 5 mg/mL Diclofenac Sodium 12.5 mg/mL Diclofenac Sodium 25 mg/mL Diclofenac Sodium 50 mg/mL Placebo 1 mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/15 (40.00%)      7/15 (46.67%)      5/15 (33.33%)      5/14 (35.71%)      6/16 (37.50%)    
Blood and lymphatic system disorders           
linphadenopathy  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Ear and labyrinth disorders           
ear pain  2/15 (13.33%)  2 1/15 (6.67%)  1 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Gastrointestinal disorders           
vomiting  2/15 (13.33%)  2 0/15 (0.00%)  0 2/15 (13.33%)  2 0/14 (0.00%)  0 1/16 (6.25%)  1
nausea  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 2/16 (12.50%)  2
gingival ulceration  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
diarrhoea  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
General disorders           
injection site pain  2/15 (13.33%)  2 2/15 (13.33%)  2 4/15 (26.67%)  5 1/14 (7.14%)  1 0/16 (0.00%)  0
swelling  1/15 (6.67%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/16 (0.00%)  0
injection site swelling  0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  2 0/14 (0.00%)  0 0/16 (0.00%)  0
Infections and infestations           
wound infection  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications           
procedural pain  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders           
pain in jaw  0/15 (0.00%)  0 4/15 (26.67%)  4 0/15 (0.00%)  0 0/14 (0.00%)  0 2/16 (12.50%)  2
joint stiffness  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders           
headache  4/15 (26.67%)  4 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 2/16 (12.50%)  4
dizziness  0/15 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0 0/14 (0.00%)  0 0/16 (0.00%)  0
lethargy  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
somnolence  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
oropharyngeal pain  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/16 (6.25%)  1
Vascular disorders           
hot flush  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Thomas Dietrich
Organization: The School of Dentistry, University of Birmingham
Phone: +44-121-46 65494
EMail: t.dietrich@bham.ac.uk
Layout table for additonal information
Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT01706588     History of Changes
Other Study ID Numbers: 12UK/DCsc04
First Submitted: October 1, 2012
First Posted: October 15, 2012
Results First Submitted: August 13, 2014
Results First Posted: August 28, 2014
Last Update Posted: September 5, 2014