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Use of analgesics in pain reduction in children

Comparison of pre-emptive ibuprofen, acetaminophen, and placebo administration in reducing pain during upper primary molar pulp therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014111017935N3
Enrollment
75
Registered
2015-04-13
Start date
2015-04-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain control during pulptherapy.

Interventions

Intervention 1: Fruit flavored Ibuprofen suspension (100 mg/5 mL)
10 mg/kg/dose one hour before treatment. Intervention 2: Fruit flavored Acetaminophen elixir (120 mg/5 mL)
15 mg/kg/dose
one hour before treatment. Intervention 3: Fruit-flavored placebo solution
one hour before treatment.
Treatment - Drugs
Placebo
Fruit flavored Ibuprofen suspension (100 mg/5 mL)
10 mg/kg/dose one hour before treatment.
Fruit flavored Acetaminophen elixir (120 mg/5 mL)
Fruit-flavored placebo solution

Sponsors

Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children ages 6–12, who has primary maxillary molar spontaneous pain; no history of any systemic disease (renal, liver or digestion diseases); no history of prolonged bleeding; no history of platelet disorders; no history of hypersensitivity or allergic reactions to analgesics or any of the drugs tested. Exclusion criteria: Patients taking analgesics within 5 hours prior to the dental procedure; uncooperative and anxious children.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain during pulp therapy. Timepoint: Right after pulp therapy. Method of measurement: Five face Visual Scale.

Secondary

MeasureTime frame
Severity of Pain. Timepoint: Right after pulp therapy. Method of measurement: Five face Visual Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Amrollahi Bioki

Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd

narges1amr@yahoo.com+98 35 3726 7525

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026