Skip to main content
OpenTrials
Completed

NCT Number: NCT03786029

Pre-emptive Analgesic Administration in Primary Tooth Extraction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Local Anesthesia Tooth Extraction

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tishreen University

Latakia, Syria

About this study

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:

  • Acetaminophen syrup: 160mg/5ml
  • Placebo solution
  • Ibuprofen suspension: 100mg/5ml

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Teeth with an abscess or infection exceeding one-third of the interradicular area (not exceeding the oral cavity) 2. Unrestorable decayed teeth. 3. Teeth with periapical / interradicular lesions.

-

Exclusion criteria

Teeth with advanced root resorption (a third of the root at least)

Treatment and study plan

Acetaminophen

Drug

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.

Other names: A

Placebo

Drug

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.

Other names: B

Ibuprofen

Drug

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.

Other names: C

Primary outcomes

  1. Assessment pain related to the injection of the local anesthesia using WBFS.

    Time frame: 30-60 seconds after injection of the local anesthesia.

    The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

    Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.

  2. Post operative pain assessment using WBFS.

    Time frame: 10 minutes - 6 hours after the extraction.

    After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale.

    Re-evaluate the pain after 15minutes from the extraction.

    The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.

Secondary outcomes

  1. Evaluate the parents' satisfaction using Likert fifth scale.

    Time frame: 6 hours after extraction.

    After the post-operation pain assessment is being done by the parents, the Likert fifth scale is used to determined the degree of parents satisfaction by choosing one of the following degrees: strongly agree, agree, neutral, disagree, strongly disagree.

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2018
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.