NCT02884921

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 21, 2016

Last Update Submit

August 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Postoperative painDental treatmentParacetamol

Outcome Measures

Primary Outcomes (1)

  • Pain measure in numerical scale

    Post operative Pain measure in numerical scale from 1 to 10

    1-24 hours

Study Arms (3)

Preemptive Paracetamol

ACTIVE COMPARATOR

Preemptive Paracetamol

Drug: Paracetamol

Post surgery Paracetamol

ACTIVE COMPARATOR

Post surgery Paracetamol

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ParacetamolDRUG

Paracetamol

Preemptive Paracetamol
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • mira koch

    Ethicla Committee Bnai Zion Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 21, 2016

First Posted

August 31, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

August 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share