Evidence map›Paper›PMID 31230016›Full record

ArticleBMJ open2019

Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.

Chunmei Zhao, Yitong Jia, Zipu Jia, Xiong Xiao, Fang Luo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03636165 (Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03636165 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)

TypeinterventionalSponsorBeijing Tiantan HospitalRan2022 to 2023Enrolled90ConditionsPain, Postoperative, Post-Craniotomy HeadacheArmsMethylprednisolone, Ropivacaine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Postcraniotomy Headache: Etiologies and Treatments.Current pain and headache reports · 2022
    Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Chunmei ZhaoDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yitong JiaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Zipu JiaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Xiong XiaoDepartment of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Fang LuoDepartment of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Beijing Tian Tan Hospital · CNCapital Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children. METHODS AND ANALYSIS: The RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8-18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle. ETHICAL APPROVAL AND DISSEMINATION: The study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03636165; Pre-results.

Indexed as

Administration, TopicalAdolescentAnesthetics, LocalChildCraniotomyDrug Therapy, CombinationHumansMethylprednisolonePostoperative PainProspective StudiesRandomized Controlled Trials as TopicRopivacaineScalpTreatment OutcomeAnesthetics, LocalMethylprednisoloneRopivacainemethylprednisolonepostoperative painprotocolrandomized controlled trialscalp infiltration

Identifiers

PMID31230016
PMCPMC6596953
OpenAlexW2950978753

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.