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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group 1 (bimodal) | Experimental | participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, |
|
| study group 2 | Experimental | Participants were given Ibuprofen three times daily for 3 days |
|
| Control group | Active Comparator | Paracetamol PRN based on parental assessment of pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 200 mg | Drug | Ibuprofen every 8 hours for three days post operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of pain control using different medications | 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 | 3 days post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of treated children | Using Childhood Oral Health Impact Scale (ECOHIS), by comparing pre and postoperative scores, lower scores mean better quality of life | 2 weeks post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| king Abdulla University Hospital | Irbid | 21166 | Jordan |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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blinding of investigators and outcome assessor was possible however no blinding of the participant
| paracetamol | Drug | Paracetamol PRN for three days |
|
|
| D010335 | Pathologic Processes |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |