Pre-emptive Analgesic Administration in Primary Tooth Extraction

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.

Conditions

• Local Anesthesia
• Tooth Extraction

Interventions

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.

Sponsors & Collaborators

• Tishreen University

  lead OTHER

Principal Investigators

• Nabih Raslan, Dr · Tishreen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2019-06-01

Completion

2019-06-10

Countries

• Syria

Study Locations