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Preemptive Analgesia Using Intravenous Paracetamol

NCT ID: NCT02884921

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-08-31

Brief Summary

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Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.

There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.

Detailed Description

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Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.

At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.

The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.

Conditions

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Adverse Anesthesia Outcome

Keywords

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Postoperative pain Dental treatment Paracetamol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Preemptive Paracetamol

Preemptive Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Paracetamol

Post surgery Paracetamol

Post surgery Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Paracetamol

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Paracetamol

Paracetamol

Intervention Type DRUG

Paracetamol

Paracetamol

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All children who require a wide treatment of caries
* Children of high score of anxious or who is stressfully

Exclusion Criteria

* Contraindication for paracetamol
* Renal or hepatic insufficiency
* Patient have history of allergy for paracetamol
* Anemia of Hgb less than 10 gr/DL
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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LUIS.GAITINI

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mira koch

Role: STUDY_CHAIR

Ethicla Committee Bnai Zion Medical Center

Other Identifiers

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BnaiZionMC-16-LG-008

Identifier Type: -

Identifier Source: org_study_id