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Trial Outcomes & Findings for Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment (NCT NCT02393339)

NCT ID: NCT02393339

Last Updated: 2021-03-03

Results Overview

This scale measures the unpleasantness or effective dimension of a child's pain experience. The child is shown a set of six cartoon faces with varying facial expressions from smile\\laughter to tears. Each face has a numerical value, from 0 (smiling face) to 5 (tears). The child selects the facial expression that best represents his \\her experience of discomfort.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

114 participants

Primary outcome timeframe

2.5 hours after taking the pre-operative analgesic.

Results posted on

2021-03-03

Participant Flow

Participant milestones

Participant milestones
Measure
Study Group
Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment paracetamol: Pre-operative administration of Paracetamol syrup
Controll Group
Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment. placebo: Pre-operative administration of placebo syrup
Overall Study
STARTED
58
56
Overall Study
COMPLETED
51
51
Overall Study
NOT COMPLETED
7
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Group
n=51 Participants
Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment paracetamol: Pre-operative administration of Paracetamol syrup
Controll Group
n=51 Participants
Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment. placebo: Pre-operative administration of placebo syrup
Total
n=102 Participants
Total of all reporting groups
Age, Continuous
6.98 years
STANDARD_DEVIATION 1.53 • n=51 Participants
7.08 years
STANDARD_DEVIATION 1.89 • n=51 Participants
7 years
STANDARD_DEVIATION 1.72 • n=102 Participants
Sex: Female, Male
Female
20 Participants
n=51 Participants
24 Participants
n=51 Participants
44 Participants
n=102 Participants
Sex: Female, Male
Male
31 Participants
n=51 Participants
27 Participants
n=51 Participants
58 Participants
n=102 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Israel
51 participants
n=51 Participants
51 participants
n=51 Participants
102 participants
n=102 Participants

PRIMARY outcome

Timeframe: 2.5 hours after taking the pre-operative analgesic.

This scale measures the unpleasantness or effective dimension of a child's pain experience. The child is shown a set of six cartoon faces with varying facial expressions from smile\\laughter to tears. Each face has a numerical value, from 0 (smiling face) to 5 (tears). The child selects the facial expression that best represents his \\her experience of discomfort.

Outcome measures

Outcome measures
Measure
Study Group
n=51 Participants
Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment paracetamol: Pre-operative administration of Paracetamol syrup
Controll Group
n=51 Participants
Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment. placebo: Pre-operative administration of placebo syrup
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 3
5 Participants
3 Participants
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 4
0 Participants
2 Participants
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 0
20 Participants
20 Participants
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 1
7 Participants
11 Participants
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 2
10 Participants
9 Participants
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Wang-Baker Scale 5
9 Participants
6 Participants

Adverse Events

Study Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controll Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Avia Fux-Noy

Hadassah School of Dental Medicine, P.O.Box 12272

Phone: +972507410935

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place