Postoperative PainPhase 2NCT02401529
Effect of Steroids on Post-tonsillectomy Morbidities
A Phase 2 study testing IV dexamethasone, Oral prednisolone and Paracetamol in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by King Fahd General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- IV dexamethasone, Oral prednisolone and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Being tested
- IV dexamethasone, Oral prednisolone, Paracetamol, IV saline
- Keywords
- Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV dexamethasoneDrug
Also called Decadron
0.15 mg/kg
Oral prednisoloneDrug
Also called Predosone
0.25mg/kg/day for 7 days then tapering for next 7 days
ParacetamolDrug
Also called Adol
acetaminophen 15 mg/kg/dose every 6 hours
IV salineDrug
Also called Saline
IV saline
| Study group | Role | What they receive |
|---|---|---|
| IV dexamethasone and oral Prednisolone | Experimental | 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). Receives: Drug: IV dexamethasone; Drug: Oral prednisolone; Drug: Paracetamol |
| Placebo | Active comparator | Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Receives: Drug: Paracetamol; Drug: IV saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: The severest pain grade felt within a week
Duration of Post-operative Pain
4 selections (1 day, 2 days, 3 days, if more specify)
Measured: number of days at which pain was experienced within the the 1st sevn days post -surgery
Occurence of Post-operative Nausea
Postoperative nausea occurence (yes, no)
Measured: 7 days
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)
Measured: onset of 1st ocurence of nausea attack within the 1st week post-surgery
Duration of Post-operative Nausea
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
Measured: 7 days
Occurence of Postoperative Vomiting
Postoperative vomiting occurrence (yes, no)
Measured: 7 days
Total Number of Post-operative Vomiting Episodes
Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
Measured: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery
Secondary outcomes (3)
Onset of 1st Post-operative Oral Intake
feeding onset (1st day i. surgery day, 2nd day, 3rd day)
Measured: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
Average Amount of Meal Per Day
adequacy of meals (inadequate, adequate)
Measured: 3 days
Average Frequency of Meals Per Day
average frequency of meals (1 meal, 2 meals, if more specify)
Measured: average number of meals consumed per day for the 1st three days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahd General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Faris Bahammam, King Fahd General Hospital
- Investigators
- Dr.Faris A Bahammam, MD, Principal investigator, ORL and Head & Neck Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401529
- Sponsor's protocol ID
- Bahammam-1
- Status last verified
- Jun 2015
- First submitted
- 21 Mar 2015
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Elhakim M, Ali NM, Rashed I, Riad MK, Refat M. Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. Can J Anaesth. 2003 Apr;50(4):392-7. doi: 10.1007/BF03021038. English, French.
PubMed 12670818Weimert TA, Babyak JW, Richter HJ. Electrodissection tonsillectomy. Arch Otolaryngol Head Neck Surg. 1990 Feb;116(2):186-8. doi: 10.1001/archotol.1990.01870020062016.
PubMed 2297411Leach J, Manning S, Schaefer S. Comparison of two methods of tonsillectomy. Laryngoscope. 1993 Jun;103(6):619-22. doi: 10.1288/00005537-199306000-00008.
PubMed 8502095Jordan K, Sippel C, Schmoll HJ. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: past, present, and future recommendations. Oncologist. 2007 Sep;12(9):1143-50. doi: 10.1634/theoncologist.12-9-1143.
PubMed 17914084Baxendale BR, Vater M, Lavery KM. Dexamethasone reduces pain and swelling following extraction of third molar teeth. Anaesthesia. 1993 Nov;48(11):961-4. doi: 10.1111/j.1365-2044.1993.tb07474.x.
PubMed 8250191Browning GG. Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a yet unanswered conundrum. Clin Otolaryngol. 2010 Oct;35(5):417. doi: 10.1111/j.1749-4486.2010.02211.x. No abstract available.
PubMed 21108754Hermans V, De Pooter F, De Groote F, De Hert S, Van der Linden P. Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Br J Anaesth. 2012 Sep;109(3):427-31. doi: 10.1093/bja/aes249.
PubMed 22879656Park SK, Kim J, Kim JM, Yeon JY, Shim WS, Lee DW. Effects of oral prednisolone on recovery after tonsillectomy. Laryngoscope. 2015 Jan;125(1):111-7. doi: 10.1002/lary.24958. Epub 2014 Oct 7.
PubMed 25291409Andersen R, Krohg K. Pain as a major cause of postoperative nausea. Can Anaesth Soc J. 1976 Jul;23(4):366-9. doi: 10.1007/BF03005916.
PubMed 7347McKean S, Kochilas X, Kelleher R, Dockery M. Use of intravenous steroids at induction of anaesthesia for adult tonsillectomy to reduce post-operative nausea and vomiting and pain: a double-blind randomized controlled trial. Clin Otolaryngol. 2006 Feb;31(1):36-40. doi: 10.1111/j.1749-4486.2006.01141.x.
PubMed 16441800Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8.
PubMed 3457335Campbell WI, Kendrick RW. Postoperative dental pain--a comparative study of anti-inflammatory and analgesic agents. Ulster Med J. 1991 Apr;60(1):39-43.
PubMed 1853495Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
PubMed 10625002Alexander TH, Weisman MH, Derebery JM, Espeland MA, Gantz BJ, Gulya AJ, Hammerschlag PE, Hannley M, Hughes GB, Moscicki R, Nelson RA, Niparko JK, Rauch SD, Telian SA, Brookhouser PE, Harris JP. Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease. Otol Neurotol. 2009 Jun;30(4):443-8. doi: 10.1097/MAO.0b013e3181a52773.
PubMed 19395984Thomas S, Beevi S. Epidural dexamethasone reduces postoperative pain and analgesic requirements. Can J Anaesth. 2006 Sep;53(9):899-905. doi: 10.1007/BF03022833.
PubMed 16960268
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroids on Post-tonsillectomy Morbidities
- ClinicalTrials.gov ID
- NCT02401529
- Acronym / sponsor ID
- Bahammam-1
- Keywords
- Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Fahd General HospitalOther government
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 15 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV dexamethasone and oral Prednisolone | Experimental | Drug: IV dexamethasone, Drug: Oral prednisolone, Drug: ParacetamolSingle 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). |
| Placebo | Active comparator | Drug: Paracetamol, Drug: IV salinePlacebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV dexamethasoneAlso: Decadron0.15 mg/kg | Drug | IV dexamethasone and oral Prednisolone |
| Oral prednisoloneAlso: Predosone0.25mg/kg/day for 7 days then tapering for next 7 days | Drug | IV dexamethasone and oral Prednisolone |
| ParacetamolAlso: Adolacetaminophen 15 mg/kg/dose every 6 hours | Drug | IV dexamethasone and oral Prednisolone, Placebo |
| IV salineAlso: SalineIV saline | Drug | Placebo |
Primary outcome
Maximum Severity of Post-operative Pain
Time frame: 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
Time frame: 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
Time frame: 7 days
Postoperative nausea occurence (yes, no)
Onset of Post-operative Nausea
Time frame: 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
Time frame: 7 days
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
Occurence of Postoperative Vomiting
Time frame: 7 days
Postoperative vomiting occurrence (yes, no)
Total Number of Post-operative Vomiting Episodes
Time frame: 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)
3 secondary outcomes
Onset of 1st Post-operative Oral Intake
Time frame: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
Average Amount of Meal Per Day
Time frame: 3 days
Average Frequency of Meals Per Day
Time frame: average number of meals consumed per day for the 1st three days post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12670818Elhakim M, Ali NM, Rashed I, Riad MK, Refat M. Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. Can J Anaesth. 2003 Apr;50(4):392-7. doi: 10.1007/BF03021038. English, French.
- Background: PubMed 2297411Weimert TA, Babyak JW, Richter HJ. Electrodissection tonsillectomy. Arch Otolaryngol Head Neck Surg. 1990 Feb;116(2):186-8. doi: 10.1001/archotol.1990.01870020062016.
- Background: PubMed 8502095Leach J, Manning S, Schaefer S. Comparison of two methods of tonsillectomy. Laryngoscope. 1993 Jun;103(6):619-22. doi: 10.1288/00005537-199306000-00008.
- Background: PubMed 17914084Jordan K, Sippel C, Schmoll HJ. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: past, present, and future recommendations. Oncologist. 2007 Sep;12(9):1143-50. doi: 10.1634/theoncologist.12-9-1143.
- Background: PubMed 8250191Baxendale BR, Vater M, Lavery KM. Dexamethasone reduces pain and swelling following extraction of third molar teeth. Anaesthesia. 1993 Nov;48(11):961-4. doi: 10.1111/j.1365-2044.1993.tb07474.x.
- Background: PubMed 21108754Browning GG. Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a yet unanswered conundrum. Clin Otolaryngol. 2010 Oct;35(5):417. doi: 10.1111/j.1749-4486.2010.02211.x. No abstract available.
- Background: PubMed 22879656Hermans V, De Pooter F, De Groote F, De Hert S, Van der Linden P. Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Br J Anaesth. 2012 Sep;109(3):427-31. doi: 10.1093/bja/aes249.
- Background: PubMed 25291409Park SK, Kim J, Kim JM, Yeon JY, Shim WS, Lee DW. Effects of oral prednisolone on recovery after tonsillectomy. Laryngoscope. 2015 Jan;125(1):111-7. doi: 10.1002/lary.24958. Epub 2014 Oct 7.
- Background: PubMed 7347Andersen R, Krohg K. Pain as a major cause of postoperative nausea. Can Anaesth Soc J. 1976 Jul;23(4):366-9. doi: 10.1007/BF03005916.
- Background: PubMed 16441800McKean S, Kochilas X, Kelleher R, Dockery M. Use of intravenous steroids at induction of anaesthesia for adult tonsillectomy to reduce post-operative nausea and vomiting and pain: a double-blind randomized controlled trial. Clin Otolaryngol. 2006 Feb;31(1):36-40. doi: 10.1111/j.1749-4486.2006.01141.x.
- Background: PubMed 3457335Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8.
- Background: PubMed 1853495Campbell WI, Kendrick RW. Postoperative dental pain--a comparative study of anti-inflammatory and analgesic agents. Ulster Med J. 1991 Apr;60(1):39-43.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Faris A Bahammam, MD principal investigator
ORL and Head & Neck Surgeon
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV dexamethasone, Oral prednisolone and Paracetamol in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by King Fahd General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Severity of Post-operative Pain (time frame: The severest pain grade felt within a week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401529, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.