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Completed

NCT Number: NCT06574516

Pain Management Following Dental Treatment Under General Anesthesia

The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure.

Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days.

pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

king Abdulla University Hospital

Irbid, 21166, Jordan

About this study

After ensuring the fulfillment of inclusion criteria, data were collected on three phases as follows:

Pre-Operative By interviewing the parents preoperatively during the waiting time, consent was obtained via a consent form , sociodemographic data (name, age, and date of the operation) were also collected using parental questionnaire .

Preoperative pain was measured using WBFPRS. Pre- and postoperative pain scales were explained to parents by the research assistant.

Intra-Operative Data were collected on anesthesia protocol , and dental treatment performed.

Anesthesia Protocol Data about anesthesia protocol were collected to ensure fulfilment of inclusion criteria, this includes mode of induction (IV or inhalational), tube type (nasal or oral), tube size, intra-operative medications (Dexamethasone and analgesia) doses and repetition , cases which did not fulfil the anesthesia protocol were excluded.

Dental Treatment Performed Data on dental procedures were collected including number of extracted teeth, location of extracted teeth (anterior, posterior), and length of dental procedure (in minutes)

Post-Operative Parents were interviewed in the hospital prior to discharge to assess pain 2 hours post operatively using parent's postoperative pain measure (PPPM).

Phone interviews were done to assess postoperative pain using PPPM at home by the same parent at the following intervals: on the night of the procedure, the next day before bed and on the third day before bed. Adherence of parents to pain control prescription was also reported.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fit and healthy patients, ASA I without cognitive or mental disabilities.
  • Aged between 4-8 years.
  • No preoperative moderate to severe pain.
  • Not receiving pain medication prior to GA.
  • Not allergic to any of the prescribed medications.
  • Undergoing at least one posterior tooth extraction.
  • Parent signed the consent form.

Exclusion criteria

  • Children requiring extraction of permanent molars to ensure standardization.
  • Patients who had no extractions at all.
  • Cases of difficult intubation as pain of difficult intubation could be confused with dental pain
  • Cases where it was necessary to repeat intra-operative analgesic medication (Fentanyl).
  • Diclofenac sodium suppository was not given at the end of the procedure.
  • Anesthetist did not follow the standardized anesthesia protocol existing in KAUH like cases where a sedative medication like Ketamine was given preoperatively.

Treatment and study plan

Ibuprofen 200 mg

Drug

Ibuprofen every 8 hours for three days post operatively

Other names: Brufen

Paracetamol

Drug

Paracetamol PRN for three days

Other names: Panadol

Primary outcomes

  1. Efficacy of pain control using different medications

    Time frame: 3 days post operative

    Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain

Secondary outcomes

  1. Quality of life of treated children

    Time frame: 2 weeks post operative

    Using Childhood Oral Health Impact Scale (ECOHIS), by comparing pre and postoperative scores, lower scores mean better quality of life

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 28, 2024
Registry last updated
Sep 4, 2024

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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