CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 66 enrolled
Drug / intervention
Acetaminophen +2 moredrug
Likely dose
Acetaminophen 320mgfrom record
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Search/NCT03786029
NCT03786029Phase 3Completed
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Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study

Tishreen University·interventional·Posted Dec 24, 2018·Updated Jun 18, 2019

In Brief

A Phase 3 clinical trial evaluating Acetaminophen, Placebo, and 1 other intervention for Local Anesthesia and Tooth Extraction. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Brief Summary: Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction. Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocal Anesthesia, Tooth Extraction
CountriesSyria
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartApr 1, 2019
Primary CompletionJun 1, 2019
Study CompletionJun 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.5 years ago

Interventions

Acetaminophendrug

Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.

Placebodrug

Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.

Ibuprofendrug

Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.