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Completed

NCT Number: NCT04730297

Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery

To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.

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Key information

Conditions

To Control Pain After Third Molar Surgery

Age range

15 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maria Paola Cristalli

Roma, 00100, Italy

About this study

Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra two days

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy status (ASA class I);
  • nonsmoker;
  • not pregnant or breastfeeding;
  • no medication consumption in the past 21 days;
  • good oral hygiene;
  • bony impaction of one mandibular third molars;
  • the presence of the first and second molars;
  • compliance to cooperate with the research protocol.

Exclusion criteria

  • chronic systemic disease;
  • medications with potential interaction to paracetamol-codeine or ibuprofen;
  • a history of intolerance or hypersensitivity to the study drugs;
  • any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.

Treatment and study plan

paracetamol 500 mg plus codeine 30 mg preoperative administration

Drug

each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg

Other names: GROUP A

ibuprofen 400 mg preoperative administration

Drug

each patient 30 minutes before surgery received ibuprofen 400 mg

Other names: GROUP B

Placebo oral tablet preoperative administration

Drug

each patient 30 minutes before surgery received placebo

Other names: GROUP C

Primary outcomes

  1. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day]

    In stage 1, the objective was to misure the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")

  2. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single

    dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  3. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  4. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  5. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  6. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo

  7. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  8. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  9. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  10. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

  11. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)

    Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]

    In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.

Secondary outcomes

  1. Number of patients requiring rescue therapy

    Time frame: until 12-hours after surgery and over extra two days

    outcomes involved the number of patients requiring rescue therapy

  2. first postoperative use of analgesics

    Time frame: until 12-hours after surgery

    time of the first intake

  3. total postoperative use of analgesics

    Time frame: until 12-hours after surgery and over extra two days

    total amount of additional medication

Other outcomes

  1. Compare the efficacy of the same drugs

    Time frame: up to 48 hours after stage 1

    Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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