NCT03786029

Pre-emptive Analgesic Administration in Primary Tooth Extraction

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Tishreen University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background and Aims: The pain could be a problem for the patients during the first few hours after the extraction because of both soft and hard tissues trauma during the operation, despite that the local anesthesia will last for a long time in most of the cases. There are no enough studies that ensure the validity of giving any analgesic in reducing injection pain and post-operative pain in primary tooth extraction so far. Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated medication bottles, which are identical, numbered and containing the same amount of pre-calibrated dosages, as per the following portions: 1. Acetaminophen syrup: 160mg/5ml 2. Placebo solution 3. Ibuprofen suspension: 100mg/5ml

Conditions

• Local Anesthesia
• Tooth Extraction

Interventions

Type	Name	Description
DRUG	Acetaminophen	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.
DRUG	Placebo	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.
DRUG	Ibuprofen	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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-06-01
• Completion: 2019-06-10
• First posted: 2018-12-24
• Last updated: 2019-06-18

Locations

1 site across 1 country: Syria