Postoperative Pain, Postoperative Nausea and Vomiting
Conditions
Keywords
Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding
Brief summary
This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.
Detailed description
The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.
Interventions
DRUGIV dexamethasone
0.15 mg/kg
0.25mg/kg/day for 7 days then tapering for next 7 days
DRUGParacetamol
acetaminophen 15 mg/kg/dose every 6 hours
DRUGIV saline
IV saline
Sponsors
King Fahd General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.
Exclusion criteria
* Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Post-operative Vomiting Episodes | total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery | Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify) |
| Onset of Post-operative Nausea | onset of 1st ocurence of nausea attack within the 1st week post-surgery | Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day) |
| Duration of Post-operative Nausea | 7 days | Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify) |
| Occurence of Postoperative Vomiting | 7 days | Postoperative vomiting occurrence (yes, no) |
| Maximum Severity of Post-operative Pain | The severest pain grade felt within a week | 5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting) |
| Duration of Post-operative Pain | number of days at which pain was experienced within the the 1st sevn days post -surgery | 4 selections (1 day, 2 days, 3 days, if more specify) |
| Occurence of Post-operative Nausea | 7 days | Postoperative nausea occurence (yes, no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Amount of Meal Per Day | 3 days | adequacy of meals (inadequate, adequate) |
| Average Frequency of Meals Per Day | average number of meals consumed per day for the 1st three days post-surgery | average frequency of meals (1 meal, 2 meals, if more specify) |
| Onset of 1st Post-operative Oral Intake | Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery | feeding onset (1st day i. surgery day, 2nd day, 3rd day) |
Participant flow
Pre-assignment details
116 participants were initially considered for the study. However, only 100 were considered in the final results. some were excluded due to not matching inclusion criteria. others failed to attend follow up visits, adhere to treatment protocol or complete the questionnaire as required. Please refer to section ( period 1) for further details.
Participants by arm
| Arm | Count |
|---|---|
| IV Dexamethasone and Oral Prednisolone Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours | 50 |
| Placebo Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 2 | 6 |
| Overall Study | Protocol Violation | 5 | 0 |
Baseline characteristics
| Characteristic | IV Dexamethasone and Oral Prednisolone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 8.5 years | 8.7 years | 8.6 years |
| Sex: Female, Male Female | 16 Participants | 21 Participants | 37 Participants |
| Sex: Female, Male Male | 34 Participants | 29 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Duration of Post-operative Nausea
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
Time frame: 7 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Nausea | no nausea | 33 participants |
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Nausea | one day | 3 participants |
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Nausea | two days | 14 participants |
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Nausea | three days | 0 participants |
| Placebo | Duration of Post-operative Nausea | three days | 6 participants |
| Placebo | Duration of Post-operative Nausea | no nausea | 21 participants |
| Placebo | Duration of Post-operative Nausea | two days | 15 participants |
| Placebo | Duration of Post-operative Nausea | one day | 8 participants |
p-value: 0.012Chi-squared
Primary
Duration of Post-operative Pain
4 selections (1 day, 2 days, 3 days, if more specify)
Time frame: number of days at which pain was experienced within the the 1st sevn days post -surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Pain | one day | 36 participants |
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Pain | two days | 11 participants |
| IV Dexamethasone and Oral Prednisolone | Duration of Post-operative Pain | three days | 3 participants |
| Placebo | Duration of Post-operative Pain | one day | 23 participants |
| Placebo | Duration of Post-operative Pain | two days | 19 participants |
| Placebo | Duration of Post-operative Pain | three days | 8 participants |
p-value: 0.026Chi-squared
Primary
Maximum Severity of Post-operative Pain
5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
Time frame: The severest pain grade felt within a week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Maximum Severity of Post-operative Pain | Low disability and low intensity | 37 participants |
| IV Dexamethasone and Oral Prednisolone | Maximum Severity of Post-operative Pain | high disability and moderate intensity | 13 participants |
| IV Dexamethasone and Oral Prednisolone | Maximum Severity of Post-operative Pain | high disability and high intensity | 0 participants |
| Placebo | Maximum Severity of Post-operative Pain | Low disability and low intensity | 26 participants |
| Placebo | Maximum Severity of Post-operative Pain | high disability and moderate intensity | 21 participants |
| Placebo | Maximum Severity of Post-operative Pain | high disability and high intensity | 3 participants |
p-value: 0.033Chi-squared
Primary
Occurence of Post-operative Nausea
Postoperative nausea occurence (yes, no)
Time frame: 7 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Occurence of Post-operative Nausea | no | 33 participants |
| IV Dexamethasone and Oral Prednisolone | Occurence of Post-operative Nausea | yes | 17 participants |
| Placebo | Occurence of Post-operative Nausea | yes | 29 participants |
| Placebo | Occurence of Post-operative Nausea | no | 21 participants |
p-value: 0.016Chi-squared
Primary
Occurence of Postoperative Vomiting
Postoperative vomiting occurrence (yes, no)
Time frame: 7 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Occurence of Postoperative Vomiting | yes | 25 participants |
| IV Dexamethasone and Oral Prednisolone | Occurence of Postoperative Vomiting | no | 25 participants |
| Placebo | Occurence of Postoperative Vomiting | no | 14 participants |
| Placebo | Occurence of Postoperative Vomiting | yes | 36 participants |
p-value: 0.024Chi-squared
Primary
Onset of Post-operative Nausea
Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
Time frame: onset of 1st ocurence of nausea attack within the 1st week post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Onset of Post-operative Nausea | 1st day | 4 participants |
| IV Dexamethasone and Oral Prednisolone | Onset of Post-operative Nausea | immediately and 1st day | 3 participants |
| IV Dexamethasone and Oral Prednisolone | Onset of Post-operative Nausea | no nausea | 33 participants |
| IV Dexamethasone and Oral Prednisolone | Onset of Post-operative Nausea | immediately | 10 participants |
| Placebo | Onset of Post-operative Nausea | immediately | 8 participants |
| Placebo | Onset of Post-operative Nausea | 1st day | 11 participants |
| Placebo | Onset of Post-operative Nausea | no nausea | 21 participants |
| Placebo | Onset of Post-operative Nausea | immediately and 1st day | 10 participants |
p-value: 0.019Chi-squared
Primary
Total Number of Post-operative Vomiting Episodes
Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
Time frame: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Total Number of Post-operative Vomiting Episodes | once | 13 participants |
| IV Dexamethasone and Oral Prednisolone | Total Number of Post-operative Vomiting Episodes | three times | 4 participants |
| IV Dexamethasone and Oral Prednisolone | Total Number of Post-operative Vomiting Episodes | twice | 7 participants |
| IV Dexamethasone and Oral Prednisolone | Total Number of Post-operative Vomiting Episodes | more than 3 times | 1 participants |
| IV Dexamethasone and Oral Prednisolone | Total Number of Post-operative Vomiting Episodes | no vomiting | 25 participants |
| Placebo | Total Number of Post-operative Vomiting Episodes | more than 3 times | 0 participants |
| Placebo | Total Number of Post-operative Vomiting Episodes | no vomiting | 14 participants |
| Placebo | Total Number of Post-operative Vomiting Episodes | once | 9 participants |
| Placebo | Total Number of Post-operative Vomiting Episodes | twice | 19 participants |
| Placebo | Total Number of Post-operative Vomiting Episodes | three times | 8 participants |
p-value: 0.02Chi-squared
Secondary
Average Amount of Meal Per Day
adequacy of meals (inadequate, adequate)
Time frame: 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Average Amount of Meal Per Day | inadequate | 16 participants |
| IV Dexamethasone and Oral Prednisolone | Average Amount of Meal Per Day | adequate | 34 participants |
| Placebo | Average Amount of Meal Per Day | inadequate | 27 participants |
| Placebo | Average Amount of Meal Per Day | adequate | 23 participants |
p-value: 0.026Chi-squared
Secondary
Average Frequency of Meals Per Day
average frequency of meals (1 meal, 2 meals, if more specify)
Time frame: average number of meals consumed per day for the 1st three days post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Average Frequency of Meals Per Day | 1 meal | 2 participants |
| IV Dexamethasone and Oral Prednisolone | Average Frequency of Meals Per Day | 2 meals | 20 participants |
| IV Dexamethasone and Oral Prednisolone | Average Frequency of Meals Per Day | 3 meals | 28 participants |
| Placebo | Average Frequency of Meals Per Day | 1 meal | 1 participants |
| Placebo | Average Frequency of Meals Per Day | 2 meals | 34 participants |
| Placebo | Average Frequency of Meals Per Day | 3 meals | 15 participants |
p-value: 0.019Chi-squared
Secondary
Onset of 1st Post-operative Oral Intake
feeding onset (1st day i. surgery day, 2nd day, 3rd day)
Time frame: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Dexamethasone and Oral Prednisolone | Onset of 1st Post-operative Oral Intake | surgery day | 46 participants |
| IV Dexamethasone and Oral Prednisolone | Onset of 1st Post-operative Oral Intake | 1st day after surgery | 4 participants |
| Placebo | Onset of 1st Post-operative Oral Intake | surgery day | 37 participants |
| Placebo | Onset of 1st Post-operative Oral Intake | 1st day after surgery | 13 participants |
p-value: 0.017Chi-squared