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NCT Number: NCT02686021

Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction

Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, University of Basel Hospital

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
  • able to understand the study and the NRS scale

Exclusion criteria

  • simultaneous both sided extraction or only upper third molar extraction
  • general anesthesia
  • known or presumed abnormal coagulation status
  • known or presumed liver or renal dysfunction
  • contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
  • contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
  • pregnancy and breast feeding mothers

Treatment and study plan

Metamizole and Ibuprofen

Drug

Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Metamizole and Placebo

Drug

Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Ibuprofen and Placebo

Drug

Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Primary outcomes

  1. area under the curve for pain in the first 12 postoperative hours

    Time frame: first 12 postoperative hours

    The primary outcome is the area under the curve for pain in the first 12 postoperative hours, as assessed by the numeric rating scale

Secondary outcomes

  1. area under the curve for pain in the first 18 postoperative hours

    Time frame: first 18 postoperative hours

    This secondary outcome is the area under the curve for pain in the first 18 postoperative hours, as assessed by the numeric rating scale (NRS)

  2. highest pain score

    Time frame: total observation period (maximum 18 hours)

    This secondary outcome is the highest pain score registered during the observation period, as assessed by the numeric rating scale

  3. night time pain

    Time frame: first night after the intervention

    This secondary outcome is the overall pain during the first night after the intervention, as assessed by the numeric rating scale

  4. need for and timing of rescue medication

    Time frame: total observation period (maximum 18 hours)

    This secondary outcome is the marked "yes" or "no", depending on whether a rescue medication (extra pain medication) was needed or not

  5. haemorrhage requiring intervention

    Time frame: total observation period (maximum 18 hours)

    This secondary outcome is the marked "yes" or "no", depending on whether an intervention to stop haemorrhage was needed or not

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: NovIbu

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2016
Registry last updated
May 4, 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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