Adenotonsillar Hypertrophy,Under 12 Years.NCT01267942
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
A study testing Enhancin in people with Adenotonsillar Hypertrophy,Under 12 Years., run by University of Nairobi at 1 site in Kenya.
Trial summary
Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Adenotonsillar Hypertrophy,Under 12 Years.
- What is being tested?
- Enhancin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteKenya
- Study dates
- May 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.
Who cannot join
- Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.
Read the detailed description
Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.
- Being tested
- Enhancin
- Keywords
- Adenotonsillectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnhancinDrug
Also called Augmentin., Clavulin., Myoclav., Co- amoxiclav
Intravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent.
Oral dose of the same at the same dosage for the active comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous intraoperative Enhancin | Experimental | Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period. Receives: Drug: Enhancin |
| Postoperative oral Enhancin. | Active comparator | Patients received postoperative oral Enhancin for five days in addition to oral Paracetamol for the same duration. They did not receive an antibiotic during the operation. Receives: Drug: Enhancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSTOPERATIVE FEVER
Temperature monitored at 1st ,4th and 7th postoperative days.
Measured: OPERATION DAY TO 7 DAYS POSTOPERATIVELY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenotonsillar Hypertrophy,Under 12 Years.Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Investigators
- Musyoka D Mutiso, mmed ent, Principal investigator, Ministry of Health, Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267942
- Sponsor's protocol ID
- P75/4/2008
- Status last verified
- Oct 2009
- First submitted
- 28 Dec 2010
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.
PubMed 10596882Mutiso MD, Macharia IM. Single intraoperative intravenous Co-Amoxiclav versus postoperative full oral course in prevention of postadenotonsillectomy morbidity: a randomised clinical trial. BMC Ear Nose Throat Disord. 2011 Sep 30;11:9. doi: 10.1186/1472-6815-11-9.
PubMed 21961644
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT01267942
- Acronym / sponsor ID
- P75/4/2008
- Keywords
- Adenotonsillectomy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.
Detailed description
Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous intraoperative Enhancin | Experimental | Drug: EnhancinPatients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period. |
| Postoperative oral Enhancin. | Active comparator | Drug: EnhancinPatients received postoperative oral Enhancin for five days in addition to oral Paracetamol for the same duration. They did not receive an antibiotic during the operation. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.
Key exclusion criteria (1 listed)
- Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.
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 |
|---|---|---|
| EnhancinAlso: Augmentin., Clavulin., Myoclav., Co- amoxiclavIntravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent. Oral dose of the same at the same dosage for the active comparator arm. | Drug | Intravenous intraoperative Enhancin, Postoperative oral Enhancin. |
Primary outcome
POSTOPERATIVE FEVER
Time frame: OPERATION DAY TO 7 DAYS POSTOPERATIVELY
Temperature monitored at 1st ,4th and 7th postoperative days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
- Background: PubMed 10596882Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.
- Derived from this study: PubMed 21961644Mutiso MD, Macharia IM. Single intraoperative intravenous Co-Amoxiclav versus postoperative full oral course in prevention of postadenotonsillectomy morbidity: a randomised clinical trial. BMC Ear Nose Throat Disord. 2011 Sep 30;11:9. doi: 10.1186/1472-6815-11-9.
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.
Musyoka D Mutiso, mmed ent principal investigator
Ministry of Health, Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancin in people with Adenotonsillar Hypertrophy,Under 12 Years., run by University of Nairobi at 1 site in Kenya.
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 29 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
POSTOPERATIVE FEVER (time frame: OPERATION DAY TO 7 DAYS POSTOPERATIVELY). 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 NCT01267942, which also lists 2 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 29 Dec 2010.