Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection (RCT)

NCT03184649 | Unknown Phase 1

• 1 other identifier: RAElshenawy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial

Conditions

Analgesic Drugs; Pain Relief

Outcome Measures

Primary Outcomes (1)

• categorical score

  mild, moderate, sever, very sever

  1 hour

Secondary Outcomes (1)

• binary

  1 day

Study Arms (3)

intervention arm

EXPERIMENTAL

Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott) will be given 30 min before injection of local anesthesia. Then pain scores will be recorded from 0-4.

Drug: Ibuprofen

intervention

EXPERIMENTAL

Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline) will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.

Drug: paracetamol

comparator

PLACEBO COMPARATOR

A fruit-flavored orange color placebo solution will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.

Dietary Supplement: A fruit-flavored orange color placebo solution

Interventions

Ibuprofen DRUG

It is a pre-analgesic will be taken before painful procedures.

Also known as: Ibufen®

intervention arm

paracetamol DRUG

it is a pre-analgesic drug will be taken before painful procedure.

Also known as: calpol®

intervention

A fruit-flavored orange color placebo solution DIETARY_SUPPLEMENT

orange juice as a comparative group.

Also known as: orange juice

comparator

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-12 years who need extractions under local anesthesia.
• Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.
• Children and parents who agree to wait for the stipulated time before and after the extraction.

You may not qualify if:

• Children with acute pain.
• Patients taking analgesics within 5 hours prior to the dental extraction.
• Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.
• Patients without a home telephone or without parental supervision for the post- operative period.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 02, Egypt

Location

Related Publications (1)

• Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.

  PMID: 17397460 RESULT

Related Links

• Description paper

MeSH Terms

Interventions

Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• fatma A. Elshehaby, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: statistician will be blind only
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: three groups, two for intervention and one for comparative group

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: May 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)