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

Pain Relief Clinical Trial

Official title:

The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03184649
• Other study ID #: RAElshenawy
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: June 9, 2017
• Last updated: June 11, 2017
• Start date: May 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

1. Diagnosis:

1. Diagnostic chart will be filled with personal, medical and dental history. DMF and def.

2. Clinical examination (intra oral and extra oral) will be done by mirror and probe to assess the inclusion criteria. All materials will be packaged in sterilizations wraps and autoclave following the required bio safety standards.

2. Intervention:

Experimental Groups:

Group 1: Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott). Group 2: Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline).

Comparative Group:

Group 3: A fruit-flavored orange color placebo solution.

Clinical procedure:

1. The drugs in all of the groups will be prepared in a fruit-flavored solution of the same color and scent.

2. Patients will be blind to one of the three pre-treatment drug groups.

3. Containers of each solution will be prepared and number-coded with the slips of paper by the assistant supervisor. The containers will be the same for all treatment groups except for the number coded with slips of paper.

4. Both the researcher and the child/parent will be blind to the content of the container.

5. The assigned solution will be taken by the patient at various times before administration of the local anesthetic agent. Ibuprofen 30 min before injection of local anesthesia paracetamol 60 min before injection of local anesthesia Placebo solution 60 min before injection of local anesthesia

6. The time of the preoperative solution administration will be recorded on the data sheet.

7. Topical anesthesia in the form of benzocaine gel 20% will be applied to the dried mucosa. All the children will be given 2% lidocaine with a 1:80,000 epinephrine injection for local anesthesia sufficient for obtaining adequate anesthesia.

8. All teeth will be extracted with a minimum of surgical trauma in an uncomplicated fashion.

Recording data

1. Pain scores will be recorded in the Pediatric Dental Clinic using a five-face scale that had been previously validated.

2. This scale has shown good construct validity as a self-report pain measure. It measures an affective dimension of a child's pain experience after injection and teeth extraction and is used in children aged 7-12 years.

3. It is easy to use and giving consistent scores from 0 to 4. It can be used for the subjective evaluation of feelings after the performance of painful dental procedures.

4. The child will be shown to a set of five cartoon faces with varying facial expressions ranging from a smile/laughter to tears. The scores given are: (0) No sign of pain. (1) Mild pain. (2) Moderate pain. (3) Severe pain. (4) Very severe pain.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 52
• Est. completion date: December 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Children aged 7-12 years who need extractions under local anesthesia.

2. Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.

3. Children and parents who agree to wait for the stipulated time before and after the extraction.

Exclusion Criteria:

1. Children with acute pain.

2. Patients taking analgesics within 5 hours prior to the dental extraction.

3. Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.

4. Patients without a home telephone or without parental supervision for the post- operative period.

Related Conditions & MeSH terms

• Analgesic Drugs
• Pain Relief

Intervention

Drug:
• Ibuprofen
It is a pre-analgesic will be taken before painful procedures.
• paracetamol
it is a pre-analgesic drug will be taken before painful procedure.

Dietary Supplement:
• A fruit-flavored orange color placebo solution
orange juice as a comparative group.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	categorical score	mild, moderate, sever, very sever	1 hour
Secondary	binary	yes or no	1 day

External Links

•   Description paper