Trial Outcomes & Findings for Injectable Diclofenac for the Prevention of Post-operative Dental Pain (NCT NCT01706588)

Last Updated: 2014-09-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery

Results posted on

2014-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Sodium 5 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 12.5 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 25 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 50 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Placebo 1 mL One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Overall Study STARTED	15	15	15	14	16
Overall Study COMPLETED	15	15	15	14	16
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Sodium 5 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 12.5 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 25 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 50 mg/mL n=14 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Placebo 1 mL n=16 Participants One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Total n=75 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 7.3 • n=5 Participants	28 years STANDARD_DEVIATION 9.4 • n=7 Participants	30 years STANDARD_DEVIATION 9 • n=5 Participants	27 years STANDARD_DEVIATION 4.5 • n=4 Participants	30 years STANDARD_DEVIATION 9.5 • n=21 Participants	28.6 years STANDARD_DEVIATION 7.94 • n=8 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants	47 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	28 Participants n=8 Participants

PRIMARY outcome

Timeframe: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery

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).

Outcome measures

Outcome measures
Measure	Diclofenac Sodium 5 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 12.5 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 25 mg/mL n=15 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Diclofenac Sodium 50 mg/mL n=14 Participants Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.	Placebo 1 mL n=16 Participants One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Area Under the Curve (AUC) of the Pain Scores.	6843 mm*minutes Standard Deviation 6259	8832 mm*minutes Standard Deviation 6330	9998 mm*minutes Standard Deviation 8080	7290 mm*minutes Standard Deviation 6509	15539 mm*minutes Standard Deviation 9279

SECONDARY outcome

Timeframe: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured from end of surgery up to 12 hours postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured from end of surgery up to 1 week postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 hour postsurgery and on Day 3

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured from end of surgery up to 12 hours postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 hour postsurgery, and on day 3 and 1 week postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every hour up to 6 hour postsurgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from signature of the informed consent to 1 week postsurgery